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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.com).
###
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
###
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.com.
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.com.
###
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).
- Colby, Colby Cheese, 8oz, 5 lb, 10 lb, or 25 lb
block, vacuum packed, Lot # 120724
- Chipotle Colby, Flavored Colby Cheese, 8 oz, 5
lb, 10 lb, or 25 lb block, vacuum packed, Lot
#120711
- Monterey Jack, Jack Cheese, 8 oz, 5 lb, 10 lb,
or 25 lb block, vacuum packed, Lot # 120719
- 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.
###
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.
###
U.S. DEPARTMENT OF HEALTH AND HUMAN RESOURCES
_________________
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
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.com
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.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
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.
 
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.com
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.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
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.
 
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 |
###
_______________________
 
____________________
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.com,
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























All information is as is and is not
intended as medical or market advise but is information for public
consumption provided by the United States of America.
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