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Medical news

 

U.S. Department of Health & Human Services

 

 

 

03/08/2013 09:00 AM EST

 
To avoid giving a false sense of security to people who are allergic to natural rubber latex, FDA is recommending that manufacturers of FDA-regulated medical products stop using statements on labels such as "latex-free" or "does not contain latex." FDA is aware of no tests that can show a medical product is completely without the natural rubber latex proteins that can cause allergic reactions.
 
Read this Consumer Update to learn more about who is at risk of allergic reactions to natural rubber latex and what you can do to prevent such reactions.

 

 

 

03/07/2013 11:33 PM EST

 
Bumble Bee Foods, LLC, is expanding a voluntary recall on specific codes of 5-ounce Chunk White Albacore and Chunk Light Tuna products. The recall has been issued because the products do not meet the company's standards for seal tightness.

 

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

 

 

 

Mobius brand Mitosol (mitomycin for solution) Kit for Ophthalmic Use: Recall-May Not be Sterile

 

 


AUDIENCE: Ophthalmology

ISSUE: Mobius Therapeutics announced that it is conducting a voluntary recall of 2 lots of Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use. The company cannot exclude the possibility that the affected lots may be non-sterile.These two lots of Mitosol (mitomycin for solution) Kits may contain a strain of yeast on one or more parts in the kit and should be considered non-sterile and unsafe for use. Use of these products could result in serious eye problems/infections, including possible blindness.

BACKGROUND:  The Mitosol Kit for Opthalmic Use is an antimetabolite indicated as an adjunct to glaucoma surgery. The recalled lot numbers and a list of the 20 states to which the product was distributed are listed in the firm press release. The recalled product was distributed between 10/22/2012 and 12/14/2012. Mobius has not received any report of adverse events related to this recall.

RECOMMENDATION: Customers with affected product in their possession should stop using the product immediately and contact Mobius at 1-877-393-6484, Option 2, for safe return of the product. 

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

 

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the complete MedWatch Safety Alert, including a link to the Firm Press Release, at:

 

 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm335167.htm


You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

FDA HHS

 

 

 

 

 

 

 

 

Qualitest Issues Voluntary, Nationwide Recall of 101 Lots of Hydrocodone Bitartrate and Acetaminophen Tablets, Usp 10 Mg/500 Mg Due to the Potential for Oversized Tablets

 

Contact:
Consumer:
1-800-444-4011

Media:
Blaine Davis
1-610- 459-7158

 

FOR IMMEDIATE RELEASE December 6, 2012 - Qualitest, a subsidiary of Endo Health Solutions, (Nasdaq: ENDP) today issued a voluntary nationwide recall for 101 lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg. This includes product with the following NDC numbers and lot numbers beginning with the letter “C”.

NDC Number Bottle Count
0603-3888-16 30
0603-3888-20 60
0603-3888-02 90
0603-3888-21 100
0603-3888-22 120
0603-3888-26 150
0603-3888-04 180
0603-3888-28 500
0603-3888-32 1000

It is possible that a number of tablets from the affected lots may exceed the weight requirement and could exceed the label claim potency requirements for the ingredients of hydrocodone bitartrate and acetaminophen. Hydrocodone bitartrate and acetaminophen 10mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain.

Bottles from the affected lots may contain tablets that have a higher dosage of acetaminophen, and as a result, it is possible that consumers could take more than the intended acetaminophen dose. Unintentional administration of tablets with increased acetaminophen content could result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. The product label warns consumers that acetaminophen overdose can potentially cause severe liver damage, at times resulting in liver transplant or death.

The affected lots, were distributed between Feb. 20, 2012 and Nov. 19, 2012 to wholesale distributors and retail pharmacies nationwide. The lot number can be found on the side of the manufacturer’s bottle. Hydrocodone Bitartrate and Acetaminophen Tablets are approximately 16.51 mm in length, pink, capsule-shaped tablets, with “3600” debossed on one side of the tablet and “V” on the other.

It is very important that consumers do not exceed the maximum daily dose in the prescribing information for this product (no more than 6 tablets per day) and are fully aware of any other prescription or over-the-counter medications they may be taking that contain acetaminophen. If there is any doubt, a consumer should consult with their health care professional.

Taking a higher dose of hydrocodone than intended could result in an increase in the severity or frequency of side effects, such as sedation or respiratory depression, particularly in patients who are elderly, have severe kidney or liver impairment, or are also taking interacting medications, for example other sedating medications or certain antidepressants.

No injuries have been reported to date.

Consumers who have the affected lots should contact Qualitest at 1-800-444-4011. Consumers who are unsure if they have the affected lot numbers or have any concerns about their product should consult their pharmacy or health care professional.

Pharmacists and wholesalers are asked to check their inventories for the affected lots, segregate any material from the lots, and to contact MedTurn at 1-800-967-5952 for instructions on product return. Pharmacies that received the affected lots will receive a copy of this press release with their recall notification information to be prominently posted in the pharmacy area.

For more information please contact Qualitest at 1-800-444-4011; Monday through Friday between the hours of 8 a.m. and 5 p.m. CST. Reports of adverse reactions or quality problems can also be reported to Qualitest at 1-800-444-4011; Monday through Friday between the hours of 8 a.m. and 5 p.m. CST.

This voluntary recall is being made with the knowledge of the U.S. Food and Drug Administration.

About Qualitest

Founded in 1983, Qualitest provides affordable, high-quality generic pharmaceuticals. Featuring a current portfolio exceeding 600 products, the company has grown significantly since its inception and is now ranked in the top ten among all suppliers of generics, based on total prescriptions filled. Qualitest is a wholly owned subsidiary of Endo Health Solutions (Nasdaq: ENDP), a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics (www.endo.com3).

###

 

12/05/2012 11:44 AM EST

 
On December 12, 2012 Bunnell Incorporated will voluntarily initiate a nationwide recall notification of Life Pulse High-Frequency Ventilator Patient Circuits.

 

. For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

 

 

 

11/30/2012 02:56 PM EST

 
Verathon Inc., Bothell, Washington, is initiating a voluntary recall of GlideScope GVL Video Laryngoscopes reusable blades that were manufactured between December 2010 and August 2011. These laryngoscope blades have been found to be prone to developing cracks and/or breaking across the tip of the blade, which potentially could result in pieces of the blade breaking off in patient’s mouths and obstructing the airway or being swallowed.

 

. For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

 

 

Mindray A3 and A5 Anesthesia Delivery System: Class I Recall - Gasket Leak

AUDIENCE: Risk Manager, Anesthesiology

ISSUE: FDA notified health professionals of a Class I Recall of the Mindray A3 and A5 Anesthesia Delivery System. The affected devices may have a gasket leak which could cause an interruption of or inadequate patient anesthesia and ventilation, temporary or permanent patient injury, or death. The gasket leak could also cause injury to bystanders and operating room personnel due to exposure from leaking anesthesia gases.

The company has identified the cause of the leak as a small step in the gasket surface which may interfere with the full seating of the gasket within the canister. The leak may be identified during the Automatic Circuit Leak and Compliance Test performed at start up and during the Manual Leak Test recommended before each use.

The devices were manufactured between May 2011 to March 2012 and distributed between May 31, 2011 to July 15, 2012.

BACKGROUND: The A3 and A5 anesthesia delivery systems are used to administer continuous or intermittent general anesthesia gases and maintain a patient’s breathing during surgery. These devices are used for both pediatric and adult patients.

Mindray first informed customers about this recall in a letter, dated August 8, 2012. The letter identified the problem with the device and possible adverse effects on patients.

RECOMMENDATION: Facilities should consider having backup equipment to maintain patient ventilation in the event of device failure due to this issue. Mindray is in the process of correcting the leak issue by replacing canister gaskets on affected devices. According to the company, as of November 14, 2012, approximately 70% of units affected by this action were corrected.


Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Recall Noticef, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm330249.htm


You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

Follow MedWatch on Twitter twitter

FDA HHS

 

 

 

11/30/2012 09:05 PM EST

 
VEGGIE PATCH is voluntarily recalling two products --The Ultimate Meatless Burger and Falafel-- due to a risk of contamination with Listeria monocytogenes. Listeria monocytogenes is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. 

 

. For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

 

11/25/2012 01:03 PM EST

 
Newman’s Own, Inc. announced the voluntary recall of Newman’s Own Lite Honey Mustard Dressing because it contains undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of a serious or life threatening allergic reaction if they consume the Newman’s Own Lite Honey Mustard Dressing with the affected time code.

 

11/21/2012 10:05 AM EST

 
Whole Foods Market is recalling the following bulk cookie items because they contain almonds and pecans, two undeclared allergens. These products were sold loose as Cookies-by-the-Pound, a self-service section in the Bakery area of the store.
11/21/2012 09:53 AM EST

 
Whole Alternatives, LLC ("Whole Alternatives") of Louisville, KY is initiating a voluntary recall of Harris Teeter brand six ounce packages of dried apricots UPC code 7203670494 and BatTis Teeter brand eight ounce packages of dried golden raisins UPC code 7203670490 because the products contain undeclared sulphur dioxide.
 

 

11/20/2012 06:08 PM EST

 
Due to the ongoing Sunland Inc. nationwide peanut recall, Boulder Ice Cream today announced a voluntary recall of certain ice cream and gelato products manufactured using peanut ingredients recalled by Sunland Inc. due to potential Salmonella contamination.

You are subscribed to Recalls, Market Withdrawals and Safety Alerts for U.S. Food & Drug Administration (FDA).

This information has recently been updated and is now available.

 

 

11/20/2012 05:33 PM EST

 
November 19, 2012 - Michael Gourmet Delicacies RECALLS Wild Alaskan Sockeye Salmon Batch# 1443 Sold in all Whole Foods in the State of Florida during the Months of June 12, 2012 Through November 16, 2012 Because of Possible Health Risk 4oz Michaels Gourmet Delicacies' Wild Alaskan Sockeye Salmon Vacuum Packed Batch# 1443 UPC Code 93573 81729 8oz Michaels Gourmet Delicacies' Wild Alaskan Sockeye Salmon Vacuum Packed Batch# 1443 UPC Code 93573 81728 16oz Michaels Gourmet Delicacies' Wild Alaskan Sockeye Salmon Vacuum Packed Batch# 1443 UPC Code 13964 11568 4oz Trimmings in Plastic Container Wild Alaskan Sockeye Salmon Batch# 1443 UPC Code 93573 81729

 

 

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NIAAA
 

Alcohol Alert

The Genetics of Alcoholism, Number 84
 

Why can some people have a glass of wine or beer with their meal without feeling compelled to drink more, whereas others can't seem to stop drinking? Can some people “hold” their liquor better than others? Does alcoholism tend to run in families? Scientists have been trying to find answers to questions such as these for several decades, seeking to identify the factors that influence a person’s risk of becoming alcohol dependent.
 

Research, to date, indicates that both your genetic makeup (i.e., the information stored in the DNA that you inherited from your parents) and your environment (i.e., how and where you live) influence your risk for alcohol abuse and alcoholism. Your genes certainly play an important role, influencing how your body responds to alcohol, how sensitive you are to its effects, and how likely you are to have a problem with alcohol. However, environmental factors—such as being surrounded by people who are heavy drinkers and who encourage you to drink—also can raise your risk for drinking too much.
 

This Alcohol Alert explores the genetics of alcoholism and provides an update on what we know about how hereditary influences drinking.

 

Mindray DS USA, Inc. Has Initiated a Voluntary Recall Affecting the
A3/A5 Anesthesia Delivery System

 


Contact:

Consumers:
1-800-288-2121 ext. 5050

Media:
US: 1-646-808-9150
China: 86-755-8188-8023

FOR IMMEDIATE RELEASE - November 14, 2012 - PRNewswire-Asia-FirstCall/ -- Mindray Medical International Limited (NYSE: MR), a leading developer, manufacturer and marketer of medical devices worldwide, has initiated a voluntary recall affecting the A3/A5 Anesthesia Delivery System.  Mindray has initiated this recall due to the possibility of a system leak resulting from improper seating of the CO2 absorbent canister gasket.

Should a system leak occur during use, fresh gas flow may be increased to compensate for any pressure loss resulting from the leak while the absorbent canister is unlocked and locked again to reseat the gasket. If the CO2 absorbent canister gasket is improperly seated, however, a potential leak will likely present itself during the Automatic Circuit Leak and Compliance Test performed at startup and the Manual Leak Test recommended to be performed before each case, at which time the absorbent canister can be unlocked and locked again to reseat the gasket.

The canister gasket subject to this recall may be identified by presence of a small “step” in the gasket surface.  A3/A5 units with this gasket may continue to be used.  The proper seating of the canister gasket should be confirmed prior to use and after CO2 absorbent is changed.

Customers who have a system(s) subject to this recall were notified by on August 8, 2012 by letter via US Postal Mail, return receipt required. To date, approximately 70% of units affected by this action have been corrected.  The issue is corrected through a replacement of the canister gasket by a Mindray Service or authorized representative.

Units with the affected canister gaskets were shipped between May 31, 2011 and July 15, 2012 in the United States, Latin America and Australia.

There have been no reports of injuries associated with this issue. Mindray became aware of the issue when a system leak was reported by a customer. The cause of the leak was determined to be the result of an improperly seated canister gasket.

Mindray has advised the US Food and Drug Administration of this voluntary recall.

Any adverse reactions or quality problems experienced with the use of this product may be reported to the U.S. Food and Drug Administration's (FDA) MedWatch Adverse Events Program either online, by regular mail or by fax.

 

 

Consumers who have questions should call:

Mindray North America at 1-800-288-2121 ext. 5050, Monday-Friday, 8:30-5:30, EST

About Mindray

We are a leading developer, manufacturer and marketer of medical devices worldwide. We maintain our global headquarters in Shenzhen, China, U.S. headquarters in Mahwah, New Jersey and multiple sales offices in major international markets. From our main manufacturing and engineering base in China, we supply through our worldwide distribution network a broad range of products across three primary business segments, namely patient monitoring and life support, in-vitro diagnostic, and medical imaging systems. For more information, please visit http://ir.mindray.com.

For investor and media inquiries please contact:

In the U.S:
Hoki Luk
Western Bridge, LLC
Tel: +1-646-808-9150
Email: hoki.luk@westernbridgegroup.com

In China:
Cathy Gao
Mindray Medical International Limited
Tel: +86-755-8188-8023
Email: cathy.gao@mindray.com

###

 

 

 

11/21/2012 05:44 PM EST

 
Rio Queen Citrus, Inc. of Mission, TX is recalling 840 cartons of 12/1 Dry Pints of Mexican cherry tomatoes in “Karol� brand boxes, because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
11/21/2012 08:45 PM EST

 
Sara Lee® is voluntarily initiating a product recall of Sara Lee Butter Streusel Coffee Cake with the UPC # 3210002342 and a BEST BY DATE of Oct. 16, 2013 as a precautionary measure because the product may contain pecans, an undeclared allergen, that are not listed on the label. This national recall affects 3,381 pounds of product with the BEST BY DATE of Oct. 16, 2013 on the side panel.

 

 

Publix Issues Voluntary Recall Multiple Cake Products

 

Contact:
Consumer:
1-800-242-1227

Media:
Maria Brous
863-680-5339
 

FOR IMMEDIATE RELEASE - November 15, 2012 - Out of an abundance of caution, Publix Super Markets is issuing a voluntary recall for forty-five (45) various cake products due to the fact that they may be adulterated with Listeria monocytogenes. Publix received notification of the contamination from our supplier, Maplehurst. This recall is for the following bakery products sold from the retail service bakery:

Scale Label Description Scale ID Number*  
7" CHOC CKIES N CRM CAKE 002-13584-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
7" CHOC CKIES N CM LAY CK 002-16466-00000  
7" W/T ICED CHOC LYR CAKE 002-16467-00000
7" DEC. BUTTERCREAM W/FIL 002-19722-00000
7" DEC WHIP TOPPING W/FIL 002-19734-00000
7" DEC FUDGE ICED W/FILL 002-19748-00000
7" DEC CRM CHSE ICED W/F 002-19759-00000
CRM CHSE 7" VAN DEC 002-92096-00000
CRM CHSE 7" CHOC DEC 002-92097-00000
CRM CHSE 1/2 & 1/2 7" DEC 002-92099-00000
 
CHOCOLATE GANACHE CAKE 002-94078-00000
DULCE DE LECHE BON BON CA 002-94003-00000
CHOC GANACHE SUPREME 002-94085-00000
CHOCOLATE GANACHE BON BON 002-94098-00000
CHOC GANACHE GRANDEUR 002-94130-00000
BUTTERCREAM 7" CHOC DEC 002-94333-00000
RASPBERRY SACHER TORTE 002-94132-00000
LATTE BLAST 002-94162-00000
WHIP TOPPING 7" CHOC DEC 002-94396-00000
WHIP TOPPING 7" 1/2-1/2 002-94420-00000
 
FUDGE ICED 7" CHOC DEC 002-94432-00000
ICE CREAM 7" CHOC DEC 002-94468-00000
ICE CREAM 7" 1/2-1/2 DEC2 002-94490-00000
BUTTERCREAM 7" 1/2-1/2 002-94502-00000
LYR W/T BLACKOUT CAKE 002-95322-00000
LYR 7" CHOCOLATE SHADOW 002-95323-00000
LYR 7" CHECKERBOARD WHOLE 002-95325-00000
LYR 7" W/T BLACK FOREST 002-95334-00000
GERMAN CHOC 7" LAYER CAKE 002-95353-00000
PEANUT BUTTER FUDGE FIX 002-95628-00000
LYR 7" CHOC W/ PISTACHIO 002-95657-00000
LYR 7" RIPPLE CAKE 002-95658-00000
LYR 7" CHOC W/MOCHA 002-95697-00000
LYR 7" CHOC W/ FUDGE 002-95663-00000
LYR 7" CHOC W/ BC 002-95664-00000
LYR 7" CHOC W/ CHERRY BC 002-95767-00000
CHEESECK TORTE 6" WHOLE 002-95770-00000
LYR 7" CHOC W/ CHOC BC 002-95954-00000
LYR 7" CHOC W/ MINT BC 002-95955-00000
GERMAN CHOC 7" CAKE 002-95958-00000
BLACK FOREST 7" CAKE 002-95970-00000
BLACK FOREST 7" CAKE 002-95970-00000
CARAMEL PECAN CRUNCH 002-94301-00000
MIDNIGHT FUDGE FANTASY 002-94254-00000
PEANUT BUTTER FDG FIX 002-94599-00000

Product was distributed to Publix stores between November 11, 2012 through November 15, 2012 to select Florida counties, including: Brevard, Charlotte, Citrus, Collier, Flagler, Hernando, Highlands, Hillsborough, Lake, Lee, Manatee, Marion, Orange, Osceola, Pasco, Pinellas, Polk, Sarasota, Seminole, Sumter, and Volusia.

Consumption of products containing Listeria monocytogenes can cause serious and sometimes fatal infection in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

“While the product is no longer available on store shelves, we have issued a voluntary recall because of our commitment to food safety and to advise our customers who may still have this product at home,” said Maria Brous, Publix media and community relations director. “No illnesses have been reported to date in connection with the 7” chocolate layer cake used to make these desserts. Consumers who have purchased the products in question may return the product to their local store for a full refund. Publix customers with additional questions may call our Customer Care Center at 1-800-242-1227 or by visiting our website at www.publix.com1. Customers can also contact the U.S. Food and Drug Administration at 1-888-SAFEFOOD (1-888-723-3366).”

Publix is privately owned and operated by its 153,000 employees, with 2011 sales of $27.0 billion. Currently Publix has 1,066 stores in Florida, Georgia, South Carolina, Alabama and Tennessee. The company has been named one of FORTUNE’s “100 Best Companies to Work For in America” for 15 consecutive years. In addition, Publix’s dedication to superior quality and customer service is recognized as tops in the grocery business, most recently by an American Customer Satisfaction Index survey. For more information, visit the company’s website, www.publix.com2.

###

 

    

 

Kenny’s Farmhouse Cheese Issues a Voluntary Recall of Various Cheeses Because of Possible Health Risk

 

Contact
Consumers:
888-571-4029
270-434-4124

 

FOR IMMEDIATE RELEASE - November 5, 2012 - Kenny’s Farmhouse Cheese (KFHC), due to the abundance of caution, is conducting a voluntary recall due to routine testing based on our company’s concern for our customers. This testing confirmed the presence of Listeria monocytogenes in a few samples of the following cheeses. At this time, no illnesses have been reported, but to ensure that all suspect product is removed from the marketplace, KFHC is initiating this voluntary recall in cooperation with the Milk Safety Branch of the Kentucky Department of Health Services (KDHS) and the US Food & Drug Administration (FDA).

  1. Colby, Colby Cheese, 8oz, 5 lb, 10 lb, or 25 lb block, vacuum packed, Lot # 120724
  2. Chipotle Colby, Flavored Colby Cheese, 8 oz, 5 lb, 10 lb, or 25 lb block, vacuum packed, Lot #120711
  3. Monterey Jack, Jack Cheese, 8 oz, 5 lb, 10 lb, or 25 lb block, vacuum packed, Lot # 120719
  4. Mild Cheddar, Cheddar Cheese, 8 oz, 5 lb, 10 lb, or 25 lb block, vacuum packed Lot # 120625

These specific cheeses and lot numbers were distributed or sold beginning on September 20th, 2012 to locations in Alabama, Indiana, Kentucky, North Carolina, Tennessee and Virginia to distributors, restaurants and farmer’s markets. Anyone that has distributed any of the cheeses identified above needs to immediately notify their customers of the voluntary recall and instruct them to return any affected cheeses for a full refund. The cost of the returned cheese will be reimbursed. Anyone identifying the above cheeses in their inventory needs to isolate/quarantine this cheese and immediately contact Kenny’s Farmhouse Cheese to arrange product return for a full refund.

Listeria monocytogenes is a bacteria which can cause serious and sometimes fatal infections in young children, frail or elderly people, pregnant women and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages, stillbirths and fetal infection among pregnant women.

If you have any questions or seek additional information, please call 888-571-4029 or 270-434-4124 or email udderway@yahoo.com. Hours of operations are Monday-Friday 9:00am-4:00pm, Saturday 9:00am-4:00pm CST.

 

Frito-Lay Issues Voluntary Recall of GRANDMA'S Peanut Butter Sandwich Crème Cookies and GRANDMA's Peanut Butter Mini Sandwich Crème Cookies Due to Undeclared Milk and Egg

 

Contact:
Consumer:
1-877-650-3479

Media:
Chris Kuechenmeister
972-334-2044 office
214-422-8901 mobile
Chris.Kuechenmeister@pepsico.com

FOR IMMEDIATE RELEASE - November 9, 2012 - PLANO, Texas – Frito-Lay announced the nationwide voluntary recall of GRANDMA'S Peanut Butter Sandwich Crème cookies and GRANDMA'S Peanut Butter Mini Sandwich Crème cookies because they contain undeclared milk and egg. People who have an allergy or severe sensitivity to milk or egg run the risk of a serious or life threatening allergic reaction if they consume the GRANDMA'S Peanut Butter Sandwich Crème and GRANDMA'S Peanut Butter Mini Sandwich Crème products. No other GRANDMA'S cookies products or flavors are impacted.

The products are sold in retail stores nationwide. The affected packages are 3.025 oz. packages of GRANDMA'S Peanut Butter Sandwich Crème cookies that have a sell-by date of March 12, 2013 or earlier and UPC code of 28400-00153; and 1.71 oz. GRANDMA'S Peanut Butter Mini Sandwich Crème cookies that have a sell-by date of May 21, 2013 or earlier and UPC code of 28400-00901. The sell-by date is located on the front of the package.

No complaint or illness has been reported to date.

The recall was initiated after it was discovered that GRANDMA'S Peanut Butter Sandwich Crème cookies and GRANDMA'S Peanut Butter Mini Sandwich Crème cookies did not list the presence of possible allergens that are included in an artificial butter flavor ingredient.

Consumers with any product noted above can return the product to retailer for a full refund, or contact Frito-Lay Consumer Relations at 1- 877-650-3479.

###

 

 

 

VOLUNTARY PRODUCT RECALL
Jimmy Dean® French Toast & Sausage Sandwich for Undeclared Allergens

 

Contact
Consumer
1-888-891-6100

Media
Sara Matheu, Jimmy Dean
1.773.580.3775
Mike Cummins, Jimmy Dean
1.312.402.7308
 

FOR IMMEDIATE RELEASE - DOWNERS GROVE, Ill. - November 10, 2012 - Jimmy Dean® is voluntarily recalling a partial production run of the brand’s butcher wrapped Food service product, Jimmy Dean French Toast & Sausage Sandwich with the code “12292P1” on the back label under the products ingredient statement, as a precautionary measure because the product may contain the undeclared allergens egg and soy, not listed on the label. This recall is due to a labeling error, in which the wrong ingredient statement may have been applied to a small number of sandwiches. The recall affects 1,110 pounds of product with the code 12292P1 on the back panel.

People who are allergic to egg or soy could have a serious or life-threatening reaction if they consume this product. For consumers who are not allergic to egg or soy, there is no safety issue with the product.

The following states are included in this recall: Iowa, Maine, Maryland, Michigan, Minnesota, Missouri, New York, Ohio, Pennsylvania and Virginia.

The item included in the voluntary recall is part of a partial production run only for Jimmy Dean French Toast & Sausage Sandwich with the UPC CODE 5450051434 and the code 12292P1 on the back of the packaging.

No other Jimmy Dean branded products, including Jimmy Dean Delights French Toast Griddlers sold at traditional grocery chains, are affected by this voluntary recall and the company has received no reports of illnesses associated with this product.

Consumers may return affected product to the store where it was purchased for a full refund. Consumers who may have questions or concerns should call the special toll-free consumer line at 1.888.914.1247. The consumer line is available from 9:00 a.m. to 5:00 p.m. Central Time Saturday and Sunday, and 7:00 a.m. to 6:00 p.m. CST Monday - Friday.

 

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Consumer Alert - Undeclared Sulfites In Fu Xiang Yuan Trading Inc "Lily Dry"

 

Contact
Consumer:
917-642-8322

FOR IMMEDIATE RELEASE - November 7, 2012 - New York State Agriculture Commissioner Darrel J. Aubertine today alerted consumers that Mayflower International Inc, aka Fu Xiang Yuan Trading Inc, located at 220 Ingrahm St. in Brooklyn, NY, is recalling Fu Xiang Yuan Trading Inc brand “Lily Dry” due to the presence of undeclared sulfites. No illnesses have been reported to date to this Department in connection with this product.

The recalled Fu Xiang Yuan Trading Inc brand “Lily Dry” is packaged in a 3.5 oz. (100 gram) plastic and foil bag. There is a UPC code of 6-944295-300176 located on the back of the package but there is no other coding on the product. The product was distributed throughout the United States and is a product of China.

Routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis of the product by Food Laboratory personnel revealed the product contained high levels of sulfites which were not declared on the label. People who have severe sensitivity to sulfites may run the risk of serious or life-threatening reactions if they consume this product. In addition, the consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites.

Consumers who have purchased the Fu Xiang Yuan Trading Inc brand “Lily Dry” should contact Liu Min at 917-642-8322.

 

###

 

Select Containers of Kroger Deluxe French Vanilla Ice Cream Recalled for Undeclared Allergen

 

Contact:
Consumer:
800-576-4377

Media:
Keith Dailey
513-762-1304

FOR IMMEDIATE RELEASE - November 6 , 2012 - The Kroger Co. (NYSE: KR) said today it is recalling select containers of Kroger Deluxe French Vanilla Ice Cream sold at the company’s Dillons, King Soopers/City Market, Fry’s Food and Smith’s Food & Drug operating divisions in 11 states because it may contain pecans not listed on the label.

Customers should return the product to stores for a full refund or replacement.

People who are allergic to pecans could have a serious or life-threatening reaction if they consume this product. For consumers who are not allergic to pecans, there is no safety issue with the product.

Dillons, Gerbes, Bakers, Fry’s, King Soopers, City Market and Smith’s stores in the following states are included in this recall: Arizona, Colorado, Idaho, Kansas, Missouri, Montana, Nebraska, Nevada, New Mexico, Utah and Wyoming.

Not included in this recall are Kroger, Ralphs, Food 4 Less, Fred Meyer and QFC stores.

  • Kroger is recalling the following ice cream: Kroger Deluxe French Vanilla Ice Cream sold in 48 fluid ounce cartons with a “sell by” date of June 12, 2013 under the following UPC Code: 11110 50718.

Kroger has removed affected items from store shelves and initiated its customer recall notification system that alerts customers who may have purchased recalled Class 1 products through register receipt tape messages and phone calls.

Consumers who have questions about this recall may contact Kroger toll-free at 800-KROGERS (800-576-4377). For more information, please visit www.kroger.com/recalls1.

Kroger, one of the world's largest retailers, employs more than 339,000 associates who serve customers in 2,425 supermarkets and multi-department stores in 31 states under two dozen local banner names including Kroger, City Market, Dillons, Jay C, Food 4 Less, Fred Meyer, Fry's, King Soopers, QFC, Ralphs and Smith's. The company also operates 788 convenience stores, 342 fine jewelry stores, 1,124 supermarket fuel centers and 37 food processing plants in the U.S. Recognized by Forbes as the most generous company in America, Kroger supports hunger relief, breast cancer awareness, the military and their families, and more than 30,000 schools and grassroots organizations. Kroger contributes food and funds equal to 160 million meals a year through more than 80 Feeding America food bank partners. A leader in supplier diversity, Kroger is a proud member of the Billion Dollar Roundtable and the U.S. Hispanic Chamber’s Million Dollar Club.

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FDA Drug Safety Podcast: Serious adverse events from accidental ingestion by children of over-the-counter eye drops and nasal sprays


Listen to This Podcast1
 Narrator: Welcome to the FDA Drug Safety Podcast from the Division of Drug Information. Today’s topic: Serious adverse events from accidental ingestion by children of over-the-counter eye drops and nasal sprays

Joan Powers, a Consumer Safety Officer in the Division, will provide you with additional information about this Communication.

Guest Speaker:  On October 25, 2012, the FDA is warning the public that accidental ingestion (swallowing) by children of non-prescription, over-the-counter eye drops used to relieve redness and nasal decongestant sprays can result in serious harm. The eye drops and nasal sprays that have been involved in the cases of accidental ingestion contain the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline. These products are sold under various brand names, as generics, and as store brands.

The cases of accidental ingestion reviewed by FDA occurred in children 5 years of age and younger. No deaths were reported; but serious events requiring hospitalization-such as coma, decreased heart rate, decreased breathing, and sedation have occurred. Ingestion of only a small amount of 1-2 mL (for reference, there are 5 mL in a teaspoon) of the eye drops or nasal spray can lead to serious adverse events in young children. Most of these redness-relief eye drops and nasal decongestant sprays currently do not come packaged with child-resistant closures, so children can accidentally ingest the drug if the bottles are within easy reach.

Consumers should store these products out of reach of children at all times. If a child accidentally swallows these eye drops or nasal decongestant spray, call the toll-free Poison Help line (1-800-222-1222) and seek emergency medical care immediately.

To protect young children from ingesting these products, earlier this year the U.S. Consumer Product Safety Commission (CPSC) published a proposed rule  requiring child-resistant packaging for redness-relief eye drops and nasal decongestant sprays.
*The proposed rule also covers products that contain xylometazoline, but products containing xylometazoline are not currently marketed.

At this time FDA recommends that Healthcare Professionals be aware of the following:

  • Cases of accidental ingestion of over-the-counter redness-relief eye drops or nasal decongestant sprays containing the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline have resulted in serious adverse events in young children 5 years of age and younger.
  • Parents and caregivers should be advised to call the toll-free Poison Help line (1-800-222-1222) and to seek emergency medical care immediately if their child accidentally swallows these eye drops or nasal decongestant sprays.
  • Consumers should be advised to store these products out of reach of children at all times.
  • Adverse events involving these eye drops or nasal decongestant sprays should be reported to the FDA MedWatch program at www.fda.gov/medwatch2.

Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information.  A link to this communication, including the complete Data Summary and Product List, can be found at www.fda.gov/DrugSafetyCommunications3.   If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

Follow us on Twitter @FDA_Drug_Info for up to the minute important drug information.  Know the moment it happens. 
 

 
 

Contact FDA

 
Toll Free
(855) 543-3784, or
(301) 796-3400
Human Drug Information
Division of Drug Information (CDER)

Office of Communications

Feedback Form7

10001 New Hampshire Avenue

Hillandale Building, 4th Floor

Silver Spring, MD 20993

 

 
 

Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Omya Voluntarily Recalls Ground Limestone Products Due to Possible Health Risk

 

Contact:
Consumer:
1-877-650-3478
 

FOR IMMEDIATE RELEASE - November 6, 2012 - Omya Inc. is voluntarily recalling certain lots of food grade ground limestone products processed at its Superior, Arizona plant because of the possible presence of Salmonella. There have been no reports of any illnesses or adverse health effects associated with any of Omya’s food grade ground limestone products. Although an investigation is still ongoing, Omya is recalling specific lots of Omya-Cal FG-4 AZ, Omya-Cal FG-10 AZ and Omya-Cal FG-15 AZ in the U.S. as a precaution.  Omya’s voluntary recall is being conducted in consultation with the U.S. Food and Drug Administration (FDA).

The most common symptoms of Salmonella infection are diarrhea, abdominal cramps and fever, which develop within eight to 72 hours of eating contaminated food. The illness usually lasts for four to seven days and most people recover without treatment. However, salmonellosis can be severe or even life threatening for infants, older people, pregnant women and those with weakened immune systems. Individuals experiencing these symptoms should seek medical attention.

Omya’s food grade ground limestone products were sold to distributors and/or manufacturers as ingredients for further processing in the U.S. The food grade products were not distributed for retail sale to consumers.
Omya is diligently investigating the possible problem and implemented additional precautionary food safety measures.

The products involved in this voluntary recall are:



 

Product Container Size Lot numbers
Omya-Cal FG-10 AZ 50 lb. bags
2500 lb. bulk bags
2000 lb. bulk bags
Z227510511
Z227500511
Z227500511
Omya-Cal FG-4 AZ 50 lb. bags
50 lb. bags
Z227510409
Z230310409
Omya-Cal FG-15 AZ 2500 lb. bulk bags
2500 lb. bulk bags
Z228400712
Z228200712
 

 “Our top priority is public safety,” said Omya chief executive officer Region Americas Tony Colak. “We have notified all of our customers who received the above-listed products, and we are working with all the government agencies that are involved out of an abundance of caution.”

All questions regarding the product recall should be directed to Omya at ph. 1-877-650-3478 (press 1 for product return assistance and press 2 for all other questions).

                                                                                                                                                       ####
 

Omya is a leading global producer of industrial minerals; mainly fillers and pigments derived from calcium carbonate and dolomite, and is a worldwide distributor of chemical products.  The company's major markets are the paper, plastics, paint/coatings/adhesives industries as well as construction, environment, agriculture, food and pharmaceuticals. Founded in 1884, Omya has a global presence extending to more than 100 locations in over 50 countries and 7,000 employees.  For more information visit the company’s Vermont website at http://omyainvermont.net1.

###

 

U.S. DEPARTMENT OF HEALTH AND HUMAN RESOURCES

 

Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

The Raymond-Hadley Corporation Expands Voluntary Recall to Include Additional Enjoy by Dates on Webmans Gluten Free Mixes Including: Double Chocolate Brownie Mix 17.2 oz., All Purpose Baking Mix 16oz., Honey Cornbread Mix 16oz., and Chocolate Cake Mix 15.3oz.

 

Contact
Consumer
1-800-252-2220

Media
Elliot Dutra
The Raymond-Hadley Corp.
1-800-252-5220, ext 303
Elliot@raymondhadley.com
 

FOR IMMEDIATE RELEASE - November 2, 2012 - The Raymond-Hadley Corp. of Spencer, NY is recalling Wegmans Gluten Free; Double Chocolate Brownie Mix, All Purpose Baking Mix, Honey Cornbread Mix, and Chocolate Cake Mix because they may be contaminated with the undeclared allergens Milk, Soy, or Pecan. People who have an allergy to these allergens run the risk of serious or life-threatening allergic reaction if they consume these products.

Wegmans brand GLUTEN FREE DOUBLE CHOCOLATE BROWNIE MIX 17.2oz., GLUTEN FREE ALL PURPOSE BAKING MIX 16oz., GLUTEN FREE HONEY CORNBREAD MIX 16oz., and GLUTEN FREE CHOCOLATE CAKE MIX 15.3oz. were all distributed in the United States through the Wegmans retail stores.

The mixes are packaged under the Wegmans brand in chipboard boxes with the following markings on the packages:

Wegmans gluten free double chocolate brownie mix 17.2oz., UPC 077890283363, With Enjoy By Dates: 30 OCT 2013 through 17 MAR 2014.

Wegmans Gluten Free All Purpose Baking Mix 16 oz., UPC 077890303412, with Enjoy By Dates: From 26 Mar 2014 through 24 Apr 2014.

Wegmans Gluten Free Honey Cornbread Mix 16oz., UPC 077890303436, with Enjoy By Dates: 25 Mar 2014 through 16 Apr 2014.

Wegmans Gluten Free Chocolate Cake Mix 15.3oz., UPC 077890283332, with Enjoy By Dates: 30 Oct 2013 through 12 Apr 2014.

The voluntary recall was initiated after it was discovered that milk, soy, and pecan was found in the mixes in packaging that did not reveal the presence of the allergens. Subsequent investigation confirms the allergens as a possible cross-contaminate in a mix ingredient.

As of November 2, 2012, 2 reports of rash have been received.

Consumers who have purchased the product listed above are urged to return it to Wegmans for a full refund. Consumers with questions may contact the manufacturer at 1-800-252-2220, Monday – Friday 8:00am – 4:30pm EDT.
 

###

Wegmans Food Markets, Inc. Announces Recall of 5 oz. and 11 oz. Organic Spinach &
Spring Mix Blend - May be Contaminated with E.coli O157 H:7
 

 

Contact:
Consumer:
1-800-934-6267

Media:
585-429-2627
or
585-301-8009
 

FOR IMMEDIATE RELEASE - November 2, 2012 - Wegmans Food Markets, Inc. is recalling approximately 31,000 lbs. of Wegmans Organic Spinach and Spring Mix sold in 5 oz. (UPC 77890 16437) and 11 oz. (UPC 77890 16411) clam shell packages in the produce department of its stores in New York, Pennsylvania, New Jersey, Virginia, Maryland, and Massachusetts between October 14 and November 1 due to possible E.coli O157 H:7.

The product is supplied to Wegmans by State Garden, Inc. based in Chelsea, Massachusetts.

The product, a blend of organic spinach and spring mix, has been associated with 16 reported illnesses in New York State from E.coli O157 H:7, which may cause a diarrheal illness, often with bloody stools. The symptoms usually appear about three days after exposure, but can range from one to nine days. Although most people recover without specific treatment in five to 10 days, some people can develop a form of kidney failure called Hemolytic Uremic Syndrome (HUS). HUS is most likely to occur in young children and the elderly. The condition can lead to serious kidney damage and even death. If you have consumed Wegmans Organic Spinach & Spring Mix and have experienced any symptoms such as diarrhea or abdominal cramps, please contact your health care provider.

Wegmans has worked closely with the New York State Department of Health and Department of Agriculture and Markets since learning that illnesses may be associated with this product.

Test results indicate that only product with a use-by-date of October 23 is connected to the reported illnesses, but out of an abundance of caution Wegmans has removed all code dates of the product from its stores and has placed phone calls to all customers who purchased the product using their Shopper Club card, regardless of the code date purchased.

Consumers who have purchased this product should discard any that remains in their homes and visit the service desk at Wegmans for a full refund. Consumers with questions may contact Wegmans consumer affairs department toll free at 1(800) WEGMANS (934-6267) Monday through Friday, between 8:00 a.m. and 5:00 p.m. Eastern time.

Wegmans Food Markets, Inc. is an 81-store supermarket chain with stores in New York, Pennsylvania, New Jersey, Virginia, Maryland, and Massachusetts.

 ___________________

Wegmans Pumpkin Roll is Recalled Because the Product May Contain Pieces of Plastic

 Contact
Consumer:
1-800-WEGMANS (934-6267)
Media:
Jo Natale, director of media relations
585-429-3627
 

FOR IMMEDIATE RELEASE - October 31, 2012 - ROCHESTER, NY - Wegmans Food Markets, Inc. is voluntarily recalling all code dates of Wegmans Pumpkin Roll (sold in the Bakery), sold between September 1 and October 30, 2012, because the product may contain pieces of clear plastic from the packaging, which may be sharp or could present a choking hazard. The following sizes are included in the recall:
 
Whole roll, 21oz - UPC: 77890-99686
Half roll, 10oz - UPC: 77890-36693
Two slices, 6oz - UPC: 77890-36684


This product is sold in all of Wegmans 81 stores in New York, New Jersey, Pennsylvania, Virginia, Maryland, and Massachusetts.

The recall was initiated by Wegmans following complaints by customers who found the plastic pieces.

Concerned customers should return the product to Wegmans service desk for a full refund. Wegmans customers with questions or concerns should contact the consumer affairs department at 1-800-WEGMANS (934-6267), Monday through Friday, 8 a.m. to 5 p.m.

Wegmans Food Markets, Inc. is an 81-store supermarket chain with stores in New York, Pennsylvania, New Jersey, Virginia, Maryland, and Massachusetts. The family-owned company, founded in 1916, is recognized as an industry leader and innovator. Wegmans has been named one of the ‘100 Best Companies to Work For’ by FORTUNE magazine for fifteen consecutive years. In 2012, Wegmans ranked #4 on the list.

 

_________________

Bolthouse Farms Voluntarily Recalls Limited Quantity
Of 16-Ounce Carrot Chips

 

Contact:
Consumer:
1-866-535-3774

Media:
Todd Putman (Bolthouse Farms)
310-857-3406

FOR IMMEDIATE RELEASE - November 1, 2012 - Bolthouse Farms is voluntarily recalling a limited quantity of Bolthouse Farms® 16-ounce Carrot Chips following a routine sampling event, conducted on October 22, 2012, by a North Carolina health official. The company was notified on October 31, 2012 that the inspection detected the possibility of Salmonella in the single16-ounce bag that was tested. Bolthouse Farms has not received any reports of consumer illness or other consumer complaints related to this product.

Out of an abundance of caution, Bolthouse Farms is retrieving the Carrot Chips from the marketplace.

No other Bolthouse Farms products are affected by this recall.

Approximately 5,600 cases of the 16-ounce bags shipped to retail customers in the United States and Canada are being recalled. The affected product is labeled as Bolthouse Farms Carrot Chips, Safeway Farms Carrot Chips, or Farm Stand Carrot Chips and has the following information and codes on the front right corner of the bags:

Bolthouse Farms Bolthouse Farms Safeway Farms* Farm Stand
BEST IF
USED BY
NOV 12 2012
04 T XXXX
BF 212 J11
UPC 71464 17209
BEST IF
USED BY
NOV 13 2012
04T XXXX
BF 212 J 12
UPC 71464 17209
BEST IF
USED BY
NOV 13 2012
06 T XXXX S2682
BF 212 J12 286
UPC 21130 70217
BEST IF
USED BY
NOV 12-13 2012
04 T XXXX
BF 212 J11-12
UPC 41163 45311

*Safeway Farms Carrot Chips are sold in Safeway stores in Ketchikan, Alaska; Arizona; California; Hawaii; Idaho; Montana; Nevada; New Mexico; Oregon; and Washington State, as well as Carrs stores in Juneau, Alaska; Pak ‘N Save stores in California; Randalls stores in Texas and Tom Thumb stores in Texas.

Consumers who have purchased these Carrot Chips with these codes and best by dates should not eat the product. Consumers are encouraged to return the product to the store where they purchased it for an exchange or full refund. Consumers also can contact Bolthouse Farms at 1-866-535-3774 (24-hours a day through Monday, November 5, 2012) for more information.

Salmonella is an organism that can cause a foodborne illness. Symptoms of infection include diarrhea, fever and abdominal cramps 12 to 72 hours after infection. The illness usually lasts four to seven days, and most persons recover without treatment.

About Bolthouse Farms
Bolthouse Farms is a farm located in California’s fertile San Joaquin Valley, known for high-quality consumer brands and innovative products. Bolthouse Farms is a market share leader in growing and distributing carrots. In addition, Bolthouse Farms produces and sells super-premium juices, smoothies, protein shakes and café beverages under the Bolthouse Farms brand name. In recent years, Bolthouse Farms diversified its offerings by launching a line of premium refrigerated yogurt dressings and extra virgin olive oil vinaigrettes. The Bolthouse Farms mission is to Inspire the Fresh Revolution™ and change the way people consume healthy foods and beverages. The company was acquired by Campbell Soup Company on Aug. 6, 2012. To learn more about the company’s mission and see the entire line of current products, visit www.bolthouse.com.

###

 

 

FDA NOTICE

MedWatch logoMedWatch - The FDA Safety Information and Adverse Event Reporting Program

Ameridose, LLC: Recall of Unexpired Products in Circulation

AUDIENCE: Risk Manager, Healthcare Professionals

ISSUE: The U.S. Food and Drug Administration announced today that Ameridose, LLC, based in Westborough, Mass., is voluntarily recalling all of its unexpired products in circulation. The FDA is currently conducting an inspection of Ameridose’s facility. Although this inspection is ongoing, the FDA’s preliminary findings have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility. Use of non-sterile injectable products can represent a serious hazard to health that could lead to life-threatening injuries.

Products from Ameridose can be identified by markings that indicate Ameridose by name or by its company logo. A complete list of all products subject to this recall can be accessed at www.ameridose.com.  

This recall is not based on reports of patients with infections associated with any of Ameridose’s products, and the agency recommended this recall out of an abundance of caution.

As new information becomes available, the FDA will issue additional public communications.

BACKGROUND: Together with the State of Massachusetts, the FDA commenced the current inspection of the Ameridose facility as part of the agency’s ongoing fungal meningitis outbreak investigation. Ameridose is a company sharing common management by the same parties as New England Compounding Center (NECC) of Framingham, Mass., the firm associated with compounded drugs linked to the ongoing fungal meningitis outbreak.

RECOMMENDATION: At this time, the FDA is recommending that health care professionals do not need to follow up with patients who received Ameridose products. Health care professionals should stop using Ameridose products at this time, and return them to the firm.

Hospitals, clinics, health care professionals, and other customers with Ameridose products on hand should contact Ameridose at 888-820-0622 to obtain instructions on how to return products to Ameridose.

Health care professionals and patients may dial the FDA’s Drug Information Line at 855-543-DRUG (3784) and press * to get the most recent information regarding the Ameridose recall and speak directly to a pharmacist.


Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA News Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm326370.htm

 

 

 

 

 

 

10/31/2012 11:13 AM EDT

 
Trexlertown, PA, Zi Xiu Tang Success, LLC is voluntarily recalling four lots of Classic Zi Xiu Tang Bee Pollen Capsules, and three lots of Ultimate Formula Capsules to the consumer level. These products have been found to contain undeclared Sibutramine. Sibutramine was a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, making these products unapproved new drugs.

 

.

 

 

This bi-weekly newsletter provided by the Office of Special Health Issues at the Food and Drug Administration (FDA) is intended to inform you of FDA-related information on a variety of topics, including new product approvals,significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other information of interest to patients and patient advocates. Subscribe or update your subscriber preferences.

 

 

PNNews abreviated masthead
 

Volume 2 | Number 22 | October 31, 2012


Public Notification: Best Share Green Coffee: Brazilian Slimming Coffee Contains Hidden Drug Ingredient


[11-8-2012] The Food and Drug Administration (FDA) is advising consumers not to purchase or use Best Share Green Coffee: Brazilian Slimming Coffee, a product promoted and sold for weight loss on various websites, including www.houseofmonet.com1 and possibly in some retail stores.

FDA laboratory analysis confirmed that Best Share Green Coffee: Brazilian Slimming Coffee contains sibutramine.   Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons.  The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.  This product may also interact, in life-threatening ways, with other medications a consumer may be taking.

Consumers should stop using this product immediately and throw it away.  Consumers who have experienced any negative side effects should consult a health care professional as soon as possible. 

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm2
  • Download form3 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Note: This notification is to inform the public of a growing trend of products marketed as dietary supplements or conventional foods with hidden drugs and chemicals.  These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.”  FDA is unable to test and identify all products marketed as dietary supplements on the market that have potentially harmful hidden ingredients.  Consumers should exercise caution before purchasing any product in the above categories. 

 Best Share Green Coffee labelGreen Coffee label

 

 

Public Notification: Beautiful Slim Body Contains Hidden Drug Ingredients


[11-8-2012] The Food and Drug Administration (FDA) is advising consumers not to purchase or use Beautiful Slim Body, a product promoted and sold for weight loss on various websites, including www.houseofmonet.com1 and possibly in some retail stores.

FDA laboratory analysis confirmed that Beautiful Slim Body contains sibutramine.   Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons.  The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.  This product may also interact, in life-threatening ways, with other medications a consumer may be taking.

Consumers should stop using this product immediately and throw it away.  Consumers who have experienced any negative side effects should consult a health care professional as soon as possible. 

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm2
  • Download form3 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Note: This notification is to inform the public of a growing trend of products marketed as dietary supplements or conventional foods with hidden drugs and chemicals.  These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.”  FDA is unable to test and identify all products marketed as dietary supplements on the market that have potentially harmful hidden ingredients.  Consumers should exercise caution before purchasing any product in the above categories. 

Beautiful Slim Body labelBeautiful Slim Body label

 

 

Fresh Express Recalls Limited Quantity of 9 oz. Spinach Due to Possible Health Risk

 

Contact
Consumer
1 - (800) 242-5472

Media
Tiffany Breaux 1 - (704) 280-5938
Barbara Hines 1 - (972) 724-3049
 

FOR IMMEDIATE RELEASE - November 7 , 2012 - Charlotte, North Carolina - Fresh Express Incorporated is conducting a voluntary, precautionary recall of a limited quantity of Fresh Express Spinach with a Use-by Date of November 7 and Product Code of S299B25 due to a possible health risk from Salmonella.

No illnesses or consumer complaints have been reported to Fresh Express at this time in association with this recall. No other Fresh Express products are subject to this recall.

The recall notification is being issued out of an abundance of caution due to an isolated instance in which a random sample yielded a positive result for Salmonella under U.S. Department of Agriculture's random sample testing program. Fresh Express is coordinating closely with regulatory officials.

Fresh Express customer service representatives are already contacting relevant retailers to confirm the recalled product has been removed from store shelves and inventories and that none is available for consumer purchase. Customers with questions are instructed to contact their usual Fresh Express customer service representative. The recalled salads were distributed primarily in the Western region of the U.S.

Consumers who may have purchased the recalled salad are asked not to eat it, but to throw it out instead. Fresh Express is offering a full refund. Consumers with questions or who would like to secure a refund may call the Fresh Express Consumer Response Center at (800) 242-5472 during the hours of 8 a.m. to 7 p.m. Eastern Daylight Time.

Specific recall information follows:

  • Product Being Recalled: Fresh Express Spinach in 9 oz. package
  • Product Code: S299B25 (located in upper right corner on front of package)
  • Use-by Date: November 7 (also located in upper right hand corner of package)
  • Distribution: Primarily in the Western region of the U.S.

Salmonella is an organism that may cause fever, nausea, vomiting, abdominal pain and possibly bloody diarrhea in healthy individuals. It can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Consumers with these symptoms should consult their health care provider.

Fresh Express Precautionary Salad Recall-11/7/12
(No other Fresh Express Salads are included in this recall)

 

Brand Product Name Size UPC Production Code Best If Used By Date POSSIBLE DISTRIBUTION STATES
Fresh Express Spinach 9 OZ. 0 71279-13204 4 S299B25 NOV7 AZ, CA, CO, HI, I D, KS, MO, MT, NE, NV, NM,OK,OR,SD, TX, UT, WA,WY



 

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.

Medication Guides are available for these products:

*biologic or drug/biologic combination

  • Abilify4 (aripiprazole) [2012 version]  
  • Absorica5 (isotrentinoin) [2012 version]
  • Abstral6 (fentanyl) [2011]
  • Aciphex7 (rabeprazole sodium) [2012 version]
  • Accutane8 (isotretinoin) [2010 version]
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  • Xyrem346 (sodium oxybate) [2005 version]
  • Updated Yervoy347* (ipilimumab) [2012 version]
  • Zarontin348 (ethosuximide) [2012 version]
  • Zelboraf349 (vemurafenib) [2011 version]
  • Zenpep350 (pancrelipase) [2011 version]
  • Zerit351 (stavudine) [2011 version]
  • Ziagen352 (abacavir sulfate) [2012 version]
  • Zipsor353 (diclofenac potassium) [2009 version]
  • Zoloft354 (sertraline hydrochloride) [2011 version]
  • Zolpidem355 (zolpidem tartrate) [2008 version] 
  • Zolpimist356 (zolpidem tartrate) [2008 version]
  • Zonegran357 (zonisamide) [2012 version]
  • Zortress358 (everolimus) [2012 version] 
  • Zyban359 (bupropion hydrochloride) [2012 version]
  • Zyprexa360 (olanzapine) [2010 version]
  • Zyprexa Relprevv361 (olanzapine) [2012 version]
 

 

The FDA Medication Guides page has been updated and is now available at http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

 

 

Charlee Bear Products Recalls “Protein Crunch Bars” Because of Possible Salmonella Health Risk

 

Contact
Consumer:
1-800-396-8893

Media:
Lori Richards
414-390–5500
lrichards@muellercommunications.com

 

FOR IMMEDIATE RELEASE - November 1, 2012 -- Charlee Bear Products announced today that it is voluntarily recalling certain lots of its Protein Crunch Bar products because they have the potential to be contaminated with Salmonella.

The following products are being recalled:

  • Charlee Bear Protein Crunch Bars – Chicken Recipe with Carrots
    5.5 oz packages; UPC Code: 8710890000
    Lot number 19812; Best by date: 07-16-2015
    Lot number 19912; Best by date: 07-17-2015
    Lot number 20012; Best by date: 07-18-2015
    Lot number 20212; Best by date: 07-20-2015
     
  • Charlee Bear Protein Crunch Bars – Chicken Recipe with Sweet Potatoes
    5.5 oz packages; UPC Code: 8710890001
    Lot number 20112; Best by date: 07-19-2015

There have been no reported animal or human illnesses related to these products.

The potential for contamination was noted after a finished product sample of Protein Crunch Bars – Chicken Recipe with Carrots (Lot no. 19812) tested positive for the presence of Salmonella. Charlee Bear is recalling that lot number and, out of an abundance of caution, the additional lot numbers identified above, all of which are manufactured by a contract manufacturer that is not otherwise involved in the production of any other products in the Charlee Bear line.

Please note that this recall applies only to these lots of Charlee Bear Protein Crunch Bars.

The recalled Charlee Bear Protein Crunch Bars were distributed nationally in September and October 2012.

Pets with Salmonella infections may have decreased appetite, fever and abdominal pain. If left untreated, pets may be lethargic and have diarrhea or bloody diarrhea, fever and vomiting. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

Individuals handling contaminated product can become infected with Salmonella, especially if they have not thoroughly washed their hands after having contact with surfaces exposed to this product. Healthy people who believe they may have been exposed to Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. According to the Centers for Disease Control, people who are more likely to be affected by Salmonella include infants, children younger than 5 years old, organ transplant patients, people with HIV/AIDS and people receiving treatment for cancer.

No illnesses have been reported to date in animals or humans in connection to these products.

Consumers who have purchased these specific recalled lots of Charlee Bear Protein Crunch Bars are urged to return them to the place of purchase for a full refund. Consumers with questions should visit www.charleebear.com1, email info@charleebear.com or call 1-800-396-8893.

At Charlee Bear, providing safe, wholesome, nutritious all-natural products is our top priority. We apologize for any inconvenience this voluntary recall may have caused and are working diligently to address the situation.

Lot codes appear below the UPC on the back panel.

UPC Codes: 8710890000 or 8710890001
Lot 19812, Best By 07/16/2015
Lot 19912, Best By 07/17/2015
Lot 20012, Best By 07/18/2015
Lot 20212, Best By 07/20/2015
Lot 20112, Best By 07/19/2015

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