FDA NEWS

HHS/FDA Grants Tentative Approval for 75th Generic Anti-Retroviral Drug as Part of President's Emergency Plan for AIDS Relief
Marketed by Macleods Pharmaceuticals, Ltd, of Kachigam, Daman, in the Republic of India, the 75th drug is 150 milligram and 300 milligram tablets of generic lamivudine, a nucleoside analog reverse-transcriptase inhibitor (nRTI), which blocks an enzyme called reverse transcriptase, important to HIV production. HIV-infected patients who take lamivudine with other anti-HIV treatments develop less opportunistic infections.

FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer
The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity.

Harry and David Issues Nationwide Allergy Alert on Undeclared Pecans in Harry and David Moose Munch Confection, Milk Chocolate Gingerbread (October 22)
Harry and David, of Medford, Oregon, is voluntarily recalling approximately 400 1 lb. 4 oz. boxes labeled Harry and David Moose Munch Confection, Milk Chocolate Gingerbread because the package may contain a different Moose Munch product which contains pecans not declared on the ingredient statement. People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they consume this product.

Recalls and Safety Alerts: Serious Injection Site Reactions with Vivitrol
FDA is alerting healthcare professionals about the risk of serious reactions at the injection site among patients treated with Vivitrol (naltrexone). Vivitrol is administered intramuscularly to treat alcohol dependence. FDA has received nearly ...

Everlasting Distributors Inc. Issues a Nationwide Recall of Fresh and Crispy Jacobina Biscuits Because of Possible Health Risks (October 29)
Everlasting Distributors Inc., Bayonne NJ is initiating a nationwide recall of all their 3.88oz (110gm) packages of Fresh and Crispy Jacobina Biscuits because it may be contaminated with Melamine.

FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes
The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.

Nestle Withdraws Nestle Farinha Lactea Cereal in the United States (November 3)
Nestle is withdrawing Nestle Farinha Lactea cereal in the United States. Nestle is taking this action as we have learned that the product may contain residual traces of a pesticide not currently approved for use on wheat in the U.S. While the pesticide is approved for use in Brazil and the noted levels are well below Brazilian standards, it is not used on wheat products in the United States and therefore there is no set standard for its presence in cereal. The pesticide is permitted in the United States on grain crops other than wheat.

Recalls and Safety Alerts: Importance of Influenza Vaccination for Health Care Personnel
As the flu season approaches, FDA is urging healthcare facilities to ensure that influenza vaccination programs are available for their personnel. Vaccinating healthcare workers will decrease the likelihood that they will contract influenza, and als...