FDA Recalls
*last updated: 30 APR, Thursday 2009
Caraco Brand of Digoxin Tablets Recalled
The
generic drug maker Caraco Pharmaceutical Laboratories Ltd. has recalled
several of its Caraco brand of digoxin tablets. The tablets are being
recalled because they may differ in size and could have more or less of
the active ingredient, digoxin, than stated on the label. Digoxin is a
drug used to treat heart failure and abnormal heart rhythms.
The
recalled products are 0.125 mg and 0.25 mg of Caraco Digoxin Tablets,
USP, distributed before March 31, 2009, which are not expired but
within the expiration date of September 2011.
Adverse events:
Tablets with a higher dose of the drug than printed on the label may be
toxic to people who take the product and who have kidney failure.
Taking too much of the drug can cause nausea, vomiting, dizziness, low
blood pressure, abnormal heartbeat, and even death. Tablets with a
lower dose of the drug than printed on the label may not be effective
and could cause abnormal heartbeat.
People at risk: Anyone who has taken the recalled Caraco brand of digoxin tablets.
You can identify the recalled products by appearance:
- Caraco
Digoxin, USP, 0.125 mg is a yellow round-shaped tablet with a cut mark
(score) in the middle on one side and the imprinted number "437" on the
other side.
- Caraco Digoxin, USP, 0.25 mg is a
white round-shaped tablet scored in the middle on one side and
imprinted with "441" on the other side.
Recommendations:
- Stop taking the recalled product and return it to your pharmacy or place of purchase.
- Contact your health care professional if you have questions.
For more information:
Manufacturer's Press Release
www.fda.gov/oc/po/firmrecalls/caraco03_09.html
Warning on Raw Alfalfa Sprouts
On April 26, 2009, the U.S. Food and Drug Administration (FDA) and
the Centers for Disease Control and Prevention (CDC) recommended that
consumers not eat raw alfalfa sprouts, including sprout blends
containing alfalfa sprouts, until further notice because the product
has been linked to Salmonella serotype Saintpaul contamination. Other types of sprouts have not been implicated at this time.
The investigation indicates that the problem may be linked to
contamination of seeds for alfalfa sprouts. FDA and CDC are issuing
this general advisory because suspect lots of seeds may be sold around
the country and may account for a large proportion of the alfalfa seeds
currently being used by sprout growers, and cases of illness are spread
across multiple states.
FDA will work with the alfalfa sprout industry to help identify
which seeds and alfalfa sprouts are not connected with this
contamination, so that this advisory can be changed as quickly as
possible.
CDC, FDA, and six state and local authorities have associated this
outbreak with eating raw alfalfa sprouts. Michigan, Minnesota,
Pennsylvania, South Dakota, Utah, and West Virginia have reported 31
cases of illness with the outbreak strain of Salmonella
Saintpaul to CDC. Most of those who became ill reported eating raw
alfalfa sprouts. Some reported eating raw sprouts at restaurants;
others reported purchasing the raw sprouts at the retail level.
The illnesses began in mid-March. Cases are still being reported,
and possible cases are in various stages of laboratory testing, so
illnesses may appear in other states. No deaths have been reported.
Salmonella is an organism that can cause serious and
sometimes fatal infections in young children, frail or elderly people,
and others with weakened immune systems. Healthy people 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 meningitis and bone infections.
This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.
For More Information
FDA Press Release
www.fda.gov/bbs/topics/NEWS/2009/NEW02001.html
Amalgamated Produce, Inc. Extends Recall to Crunchy Sprouts in the North Eastern United States Because of Possible Health Risk
FOR IMMEDIATE RELEASE -- Amalgamated Produce, Inc. is
extending its recall of April 9, 2009 to include one additional
product, labeled as either Specialty Farms Organic Crunchy Sprouts or
Organic Crunchy Pea Mix, as noted below.
These items all have a
sell-by date from 3/31/09 through 4/27/09 and are net weight 4 ounces
in plastic containers.
BRAND |
ITEM DESCRIPTION |
UPC |
|---|
Specialty Farms |
Organic Crunchy Sprouts |
8192400061 |
Specialty Farms |
Organic Crunchy Pea Mix |
" " " |
The above items are all in plastic containers.
These sprouts are being recalled because they may have the potential
to be contaminated with Listeria monocytogenes (Lm). Lm is an organism
which can cause serious and sometimes fatal infections 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.
Amalgamated Produce, Inc. voluntarily recalled sprouts April 9,
2009 after laboratory analysis found positive results. The press
release for this recall is available at the following link:
http://www.fda.gov/oc/po/firmrecalls/api04_09.html
All products produced by Amalgamated Produce, Inc. under
the brand names Specialty Farms, Vermont Sprout House,
and BroccoSprouts with a sell-by date 5/1/09 and beyond are not
included in this recall.
Products have been distributed in the following states:
- NY, NJ, CT, RI, MA, NH, VT, ME, MD, PA and Delaware
API is currently in the process of determining exactly where this
potential Lm contamination could be occurring in its facility and is
immediately remedying the potential sources as they are identified. API
hopes to return to full sprout production soon.
Consumers who have purchased this product are urged to return them
to the point of purchase for refund and may contact API with questions
at (800)358-3808 between the hours of 9:00 A.M. to 5:00 P.M. EST.
FDA Alerts the Public to Uncle Chen and Lian How Brand Expanded Recall
Sauces, oils and oil blends, in addition to dry spices, may be contaminated with Salmonella
On April 16, 2009-The U.S. Food and Drug Administration (FDA) is alerting the public to
the expanded, voluntary recall by Union International Food Company
(Union City, Calif.) of sauces, oils, and oil blends sold under the
Uncle Chen and Lian How brands.
The expanded recall is based on the investigation into the ongoing foodborne illness outbreak of
Salmonella Rissen. It is in addition to the recall announced last month by the company of its dry spice products.
The sauces, oils, and oil blends being recalled were distributed under
the Uncle Chen and Lian How brands to retailers, wholesalers,
distributors, and restaurants in the states identified to date of
Arizona, California, Nevada, Oregon, South Carolina, Texas, Utah,
Washington and Wisconsin. The products were sold in containers ranging
from 6 ounces to 1 gallon in plastic or glass bottles and are used, for
example, as spices and seasonings for cooking and as table top meal
seasonings.
A complete list of all of the products recalled by Union International Food Co. is available at:
http://www.fda.gov/oc/po/firmrecalls/unioninternational_list3.html
The company has stopped the production and distribution of these
products as the FDA, the California Department of Public Health, and
Union International Food Co. continue their investigations.
To date, 57 cases of illness caused by
Salmonella Rissen have been reported, mostly in the western region of the country.
Sprout Recall Due to Potential Contamination with Listeria
On April 9, 2009, Amalgamated Produce, Inc. (API), Bridgeport, CT.,
announced that it is voluntarily recalling certain brands of sprouts
due to potential contamination with Listeria monocytogenes, a foodborne
pathogen that can cause serious illness and death.
The
following brands with sell-by date codes March 31 through April 27,
2009, are being recalled: Specialty Farms Sprouts, Vermont Sprout
House, Nature's Promise, and BroccoSprouts. The company is also
recalling plastic bagged sprouts in a box with a sticker identifying 5
lb. bulk alfalfa, with julian dates 069 through 097. For a complete
listing of the recalled sprout products, visit http://www.fda.gov/oc/po/firmrecalls/api04_09.html.
Listeria monocytogenes can cause serious and sometimes fatal
infections 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, listeriosis can cause
miscarriages and stillbirths in pregnant women.
There
have been no cases of listeriosis reported to date in connection with
the recalled products. API is issuing this recall as a precaution.
Bacteria have been found in a sample that had been collected by state
health officials in New York.
The recalled sprouts have been distributed in CT, MA, MD, ME, NH, NJ, NY, PA, DE, VT, and RI.
If
you have purchased any of the recalled products, you should return them
to the point of purchase for a refund. You can also call API at
800-358-3808 between 9:00 a.m. to 5:00 p.m. Eastern Standard Time.
For More Information
View Photos of Product Labels
http://www.fda.gov/oc/po/firmrecalls/photos/sprouts/api04_09.html
Amalgamated Produce, Inc. Recall
http://www.fda.gov/oc/po/firmrecalls/api04_09.html
CDC Information on Listeriosis
http://www.cdc.gov/nczved/dfbmd/disease_listing/listeriosis_gi.html
FDA Information on Listeria and Pregnancy
http://www.cfsan.fda.gov/~pregnant/whillist.htm
Gurley’s Foods, Inc. Issues a Nationwide Voluntary Recall of Mountain Country Brand Garlic Pistachios
Contact:
Jerry Platt
800-426-7845
FOR IMMEDIATE RELEASE -- Willmar, MN -- April 8,
2009 --- Gurley’s Foods, Inc., of Willmar, Minnesota announced today a
voluntary recall of some lots of Mountain Country brand 1.99 Garlic
Pistachios and Mountain Country brand no price Garlic Pistachios due to
possible contamination with the Salmonella organism. The recall is a precautionary measure due to the recall expansion of Setton Pistachio of Terra Bella, Inc.
Salmonella is 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 instances, 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.
Lots included in the recall are as follows:
Mountain Country 1.99 package Garlic Pistachios (UPC 0-77449-50095-8) 2.75 oz. code 2-25-10 F.
Mountain Country no price Garlic Pistachios (UPC 0-77449-50095-8) 2.75 oz. codes: 2-24-10 F, 2-25-10 F.
Products are sold primarily in convenience stores and distributed in
the following states: CO, WY, CA, OR, WA, ID, MT, UT, AZ, PA, OK, and
NJ.
No illnesses have been reported to date in connection with this
issue. This recall is being made with the knowledge of the U.S. Food
and Drug Administration.
Consumers who have purchased any of these packaged products should
return them to the place of purchase or discard them. Consumers with
questions may contact the company at 1-800-426-7845. Office hours are 8
a.m. to 5 p.m. Monday through Friday.
FDA says to avoid pistachios amid salmonella scare
31 MAR 2009-Federal food safety officials warned Monday that consumers should stop eating all
foods containing pistachios while they figure out the source of a possible salmonella contamination.
Still reeling from the national salmonella outbreak in peanuts, the Food and Drug Administration
said central California-based Setton Pistachio of Terra Bella Inc., the
nation's second-largest pistachio processor, was voluntarily recalling
a portion of the roasted nuts it has been shipping since last fall. A
Setton spokeswoman said that amounts to more than 2 million pounds of
nuts.
"Our advice to consumers is that they avoid eating pistachio products, and that they hold onto those products," said Dr. David Acheson,
assistant commissioner for food safety. "The number of products that
are going to be recalled over the coming days will grow, simply because
these pistachio nuts have then been repackaged into consumer-level containers."
Two people called the FDA
complaining of gastrointestinal illness that could be associated with
the nuts, but the link hasn't been confirmed, Acheson said. Still, the
plant decided to shut down late last week, officials said.
The
recalled nuts represent a small fraction of the 55 million pounds of
pistachios that the company's plant processed last year and an even
smaller portion of the 278 million pounds produced in the state in the
2008 season, according to the Fresno-based Administrative Committee for
Pistachios.
For
nuts, roasting is supposed to kill the bacteria. But problems can occur
if the roasting is not done correctly or if roasted nuts are
re-contaminated.
That can happen if mice, rats or birds get into the
facility.
Last winter, a national salmonella outbreak
was blamed on a Georgia company under federal investigation for
flouting safety procedures and knowingly shipping contaminated peanuts.
The
outbreak is still ongoing. More than 690 people in 46 states have
gotten sick. Nearly 3,900 products made with peanut ingredients from
Peanut Corp of America have been recalled.
California
public health authorities have taken hundreds of samples at Setton's
processing facility, but lab results have not yet determined whether
salmonella was found at the plant, Farrar said. The food companies' own
tests of the contaminated products isolated four different types of
salmonella, but none were the same strain as the one found in the
peanuts, Acheson said.
Warning on Potentially Contaminated Cheese
Which Peregrina products are affected by this warning?
- Queso Fresco Fresh Cheese Mexican style soft cheese (two specific lots):
Queso Fresco Fresh Cheese comes in 14-ounce foil wrapped packages
marked with lot number 4469 or 4477 affixed to each package on a white
sticker and bearing UPC number 8 17424 00024 6 and Plant # 36-8431.
- Queso Cotija Molido Mexican style grated cheese:
Queso Cotija Molido Cheese comes in 15-ounce clear plastic bags that
are marked with UPC number 8 17424 00027 7 and Plant # 36-1388. The
bags do not contain a lot number or production date.
These products were distributed in early February 2009 to retail stores in
- the New York City boroughs of Brooklyn, Queens, Bronx, and Manhattan
- the Pennsylvania towns of Scranton and Hazelton
For Information please visit this link:
http://www.fda.gov/consumer/updates/cheesewarning0309.html
Melamine
Contamination in China
FDA’s
Warnings/Advisories
The FDA is advising consumers not to consume the following products because of possible melamine contamination:
- Topaz Wafer Rolls with Chocolate Flavored Cream Filling New!
- Topaz Wafer Rolls with Hazelnut Chocolate Flavored Cream Filling New!
- Topaz Wafer Rolls with Vanilla Flavored Cream Filling New!
- Topaz Wafer Rolls with Mocha Cappuccino Flavored Cream Filling New!
- G&J Hot Cocoa Stuffer Item 120144
- G&J His and Hers Hot Cocoa Set Item 120129
- G&J Cocoa item 120126, sold in 2 flavors: French Vanilla
Cocoa and Double Chocolate Cocoa
- Wonderfarm "Successful" Assorted Biscuits
- Wonderfarm "Royal Flavour" Assorted Biscuits
- Wonderfarm "Lovely Melody" Assorted Biscuits
- Wonderfarm "Daily Life" Assorted Biscuits
- Topaz Hazelnut Wafer Rolls with Hazelnut Chocolate Flavored Creme
Filling (photo
page)
- Sweet Time Christmas Dressy Bear with Chocolate Bar
- Fresh and Crispy Jacobina Biscuits
- Koala’s March Crème filled Cookies
- YILI Brand Sour Milk Drink
- YILI Brand Pure Milk Drink
- Blue Cat Flavored Drinks
- White Rabbit Candies
- Mr. Brown Mandehling Blend
Instant Coffee (3-in-1)
- Mr. Brown Arabica Instant
Coffee (3-in-1)
- Mr. Brown Blue Mountain
Blend Instant Coffee (3-in-1)
- Mr. Brown Caramel Macchiato
Instant Coffee (3-in-1)
- Mr. Brown French Vanilla
Instant Coffee (3-in-1)
- Mr. Brown Mandheling Blend
instant Coffee (2-in-1)
- Mr. Brown Milk Tea (3-in-1)
- Infant formula manufactured
in China
http://www.fda.gov/oc/opacom/hottopics/melamine.html