Wednesday, February 20, 2008

Government Looks At Meat Production After Larget Meat Recall In History.

WSJ is reporting that Lawmakers and government investigators seized on the largest meat recall in U.S. history to set the table for changes in the nation's food-safety system, especially as it applies to school lunches.

Rep. Rosa DeLauro, the Connecticut Democrat who heads a House subcommittee overseeing the Agriculture Department's budget, scheduled two food-safety hearings for March, at which top department officials are expected to testify. Wisconsin Democratic Sen. Herb Kohl, chairman of a subcommittee on agriculture appropriations, has tentatively scheduled a hearing for Feb. 28. Meanwhile, Congress's investigative arm, the Government Accountability Office, plans to look at food safety in the federal school-lunch program, which is run by the Agriculture Department.

The House Energy and Commerce Committee, whose investigators have studied food-safety issues for more than a year, has invited top executives from a half-dozen food processors, including the president of Hallmark/Westland, to a hearing Tuesday on the beef recall and other safety issues.

Under rules designed to prevent mad-cow disease, meat companies are required to report downer cows to federal authorities. An Agriculture Department rule, finalized in July 2007, allows federal veterinarians to make a case-by-case decision on such cattle; some cattle, such as those with a broken leg, are still likely to be slaughtered for meat.

But businesses don't always follow the rules. In a 2006 report, the Agriculture Department's inspector general found that most companies visited didn't have adequate plans to reduce the risk of transmitting mad-cow disease, and that the department "did not always identify these deficiencies."


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Tuesday, February 19, 2008

Mix Up Of Names Prevented Chinese Heparin Factory Inspection, FDA

Chinese Factory Linked to Drug Heparin?

That we reported last week as well as Baxter recall, the factory has not been inspected by FDA due to mixup of names. FDA has mistakenly assumed that the factory was earlier inspected while it was not. The FDA's explanation, by Joseph Famulare, deputy director of compliance for the FDA's center for drug evaluation and research, comes amid questions about the safety of different types of goods made in China and the adequacy of the FDA's inspection procedures for drugs entering the U.S. from China.
source

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Spiderman Water Bottles, Cinderella Battery-Powered Toy Cars Recalled


bullet Spiderman Water Bottles Sold Exclusively at Sears Recalled by Fast Forward Due to Choking Hazard
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Fast Forward LLC, of New York, N.Y., is voluntarily recalling about 6,600 Spiderman® Water Bottles. Screws under the bottle’s lid can come loose and fall into the cup, posing a choking hazard to children.
bullet Cinderella Battery-Powered Toy Cars Recalled by Dumar International USA Due to Fire and Burn Hazards
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Dumar International USA, of Franklin, Mass., is voluntarily recalling about 64,000 Cinderella 12-Volt Electric Ride-On Vehicles. The wires under the hood of the car and/or in the battery compartment under the seat can short circuit, posing a fire and burn hazard to children riding in the car.

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Monday, February 18, 2008

Actavis Recalls Certain Fentanyl Patches

Actavis Recalls Certain Fentanyl Patches in the US as Precaution
Fentanyl transdermal system is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around the clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids.

Media Contact:
Actavis Inc.
Sarita Thapar, PharmD
908-659-2471

FOR IMMEDIATE RELEASE -- Morristown, NJ -- February 17, 2008 -- Actavis Inc., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group hf, today announced that 14 lots of Fentanyl transdermal system CII patches sold in the United States by Actavis' subsidiary Actavis South Atlantic LLC are being voluntarily recalled from wholesalers and pharmacies as a precaution.

The recalled patches were manufactured by Corium International Inc., a contract manufacturer for Actavis, and sold nationwide in the United States by Actavis South Atlantic LLC.

Fentanyl patches sold by Actavis in Europe are not affected by this recall.

The 14 lots of Fentanyl transdermal system patches being recalled may have a fold-over defect which may cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. Although unaware of any injuries resulting from this issue Actavis, as a precaution, is recalling these lots. As per the approved product labelling for Fentanyl transdermal system, fentanyl is a potent Schedule II opioid medication. Fentanyl patches that are leaking or damaged in any way should not be used. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches that may be damaged or compromised in any way by flushing them down the toilet, using caution not to handle them directly. Damaged and/or compromised patches that have leaked gel will not provide effective pain relief.

The lots covered by this recall are: 27261 (exp 05/09), 27317 (exp 05/09), 27318 (exp 06/09), 27319 (exp 06/09), 27391 (exp 06/09), 27409 (exp 06/09), 27475 (exp 07/09), 27476 (exp 06/09), 27488 (exp 06/09), 27514 (exp 07/09), 27536 (exp 07/09), 27537 (exp 08/09), 27538 (exp 08/09), 27545 (exp 07/09), covering the following strengths: 25 mcg/hr, 50 mcg/hr, 75 mcg/hr and 100 mcg/hr.

Please note: Actavis South Atlantic LLC was formerly known as Abrika Pharmaceuticals Inc. The pouches containing the patches are labelled with an Abrika Pharmaceuticals label, but the outer carton bears the Actavis logo with the following product names:

Actavis Fentanyl Transdermal System, 25 mcg/hr. NDC 67767-120-18.
Actavis Fentanyl Transdermal System, 50 mcg/hr. NDC 67767-121-18.
Actavis Fentanyl Transdermal System, 75 mcg/hr. NDC 67767-122-18.
Actavis Fentanyl Transdermal System, 100 mcg/hr. NDC 67767-123-18.

Anyone who has fentanyl patches labelled with an Abrika or Actavis label should check them for these lot numbers.

Affected patches should not be handled directly.

Anyone with Actavis Fentanyl transdermal system patches with the above listed lot numbers should call 1 877 422 7452.

Patients using fentanyl patches who have medical questions should contact their health-care providers.

This recall is being conducted with the knowledge of the Food and Drug Administration.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.



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Mission City Press Recalls Girl's Bracelet


bullet Mission City Press Recalls Girl's Bracelet Sets Due to Violation of Lead Paint Standard
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Mission City Press, of Franklin, Tenn., is voluntarily recalling about 11,000 A Life of Faith Charm Bracelet Sets. Surface paint on the pearl white beads of the bracelet, contains excessive levels of lead, violating the federal lead paint standard.
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Bassettbaby Drop-Side Cribs Sold By Babies "R" Us stores Recalled Due to Entrapment and Strangulation Hazard


bullet Bassettbaby Drop-Side Cribs Recalled Due to Entrapment and Strangulation Hazard
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Bassettbaby, of Bassett, Va., is voluntarily recalling about 18 Wendy Bellissimo Hidden Hills Collection Drop-Side Cribs. Spindles on the drop-side of the crib could loosen creating a gap that poses an entrapment and strangulation hazard.
The following product safety recall was voluntarily conducted by the firm in cooperation with the CPSC. Consumers should stop using the product immediately unless otherwise instructed.

Name of Product: Wendy Bellissimo Hidden Hills Collection Drop-Side Cribs

Units: 18

Importer: Bassettbaby, of Bassett, Va.

Hazard: Spindles on the drop-side of the crib could loosen creating a gap that poses an entrapment and strangulation hazard.

Incidents/Injuries: Bassettbaby has received three reports of spindles coming loose. No injuries have been reported.

Description: This recall involves a full-size, drop-side crib from the Wendy Bellissimo Hidden Hills collection, model number 5446-0504. The model number is located on the bottom rail of the headboard. The crib was sold in a Navajo Pine finish. No other models are included in this recall.

Sold at: Babies "R" Us stores nationwide from November 2007 through January 2008 for about $400.

Manufactured in: China

Remedy: Consumers should stop using the crib immediately and contact Bassettbaby for a free replacement or a full refund. The firm has contacted consumers directly.

Consumer Contact:For additional information, contact Bassettbaby toll-free at (800) 308-7485 between 9 a.m. and 5 p.m. ET Monday through Friday, or visit the firm’s Web site at www.bassettbaby.com

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Nutri-Foods Recalls "Organic Sesame Seeds Natural - Unhulled"

Nutri-Foods Recalls "Organic Sesame Seeds Natural - Unhulled" Because of Possible Health Risk

Contact:
John Bettin
248-541-6820

FOR IMMEDIATE RELEASE -- February 15, 2008 -- Nutri-Foods, Inc. ("Nutri-Foods") of Royal Oak, Michigan, is recalling its .50 pound packages of "Organic Sesame Seeds Natural - Unhulled" due to possible salmonella contamination, 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 illness such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The recalled "Organic Sesame Seeds Natural - Unhulled" were sold at Nutri-Foods.

The product comes in a .50 pound clear plastic package with a product SKU #170 at the top and a "packed on" date of December 28. This product was sold from circa December 15, 2007 through January 28, 2008.

No illnesses have been reported to date in connection with this problem.

Production of the product has been suspended while the FDA and manufacturer of the product continue their investigation.

Consumers who have purchased the .50 pound package are urged to return them to Nutri-Foods for a full refund. Consumers with questions may call Nutri-Foods at (248) 541-6820 and ask for John B. or Judy.


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