FDA NEWS

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.

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.

Using Over-the-Counter Cough and Cold Products in Children
FDA supports the voluntary actions of drug manufacturers to better inform consumers about the safe and effective use of over-the-counter cough and cold medicines in children.

Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II Left Ventricular Assist System (October 24)
Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death.

Nonna's Real Italiana Cuccine Issues an Allergy Alert on Undeclared Milk, Soy, and Wheat in Stuffed Artichokes (October 22)
This product is distributed through retailers in the Greater New Orleans area including the Northshore from October 8, 2008 to October 17, 2008. The product is individually wrapped in clear plastic wrap bearing the label: "STUFFED ARTICHOKE, Net Wt. 15 oz., NONNA'S REAL ITALIANA CUCCINE".

Draft Guidance on Genetically Engineered Animals
The technology of genetic engineering offers many benefits for health, agriculture, and the environment. FDA tells how it is regulating genetically engineered animals.

Amy's Kitchen Inc. Issues Allergy Alert and Voluntary National Recall due to Possible Undeclared Milk in Tofu Scramble in a Pocket Sandwich; Lot Code H148 (November 7)
The products could cause an allergic reaction if consumed by any individuals allergic to milk. People who have an allergy or severe sensitivity to dairy products run the risk of serious or life-threatening allergic reaction if they consume the product. Consumers without milk allergies can safely consume the product.