FDA NEWS

Johnson and Johnson--Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall Of Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas) Non-Staining Due To Possible Metal Fragments (November 7)
Johnson and Johnson -- Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants' MYLICON GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide. The company is taking this action in consultation with the U.S. Food and Drug Administration (FDA). Although the potential for serious medical events is low, the company is implementing this recall to the consumer level as a precaution after determining that some bottles could include metal fragments that were generated during the manufacturing process. If any medical events were to occur, most are expected to be temporary and resolve without medical treatment. Parents who have given the product to their infant and are concerned should contact their health care provider immediately.

Improper Use of Decorative Contacts May Haunt You
Halloween is a good time to remind people that improper use of non-prescription decorative contact lenses may harm your vision

FDA Warns Bayer About Two Unapproved Aspirin Products
FDA has sent warning letters to Bayer HealthCare regarding two over-the-counter products that combine aspirin with a dietary supplement into a single pill.

Lotte USA, Inc. Initiates Nationwide Recall of Koala's March Creme filled Cookies
Lotte USA, Inc., Battle Creek, MI initiated a recall of all Koalas' March Cookies on September 29, 2008 because they were produced in China and they may be contaminated with melamine. The products are packaged in a plastic overwrap.

Mars Petcare US Issues Voluntary Recall of a Limited Number of Bags of SPECIAL KITTY Gourmet Sold at Wal-Mart locations in Fifteen States due to Potential Salmonella Contamination
Mars Petcare US today announced a voluntary recall of a limited number of bags of SPECIAL KITTY Gourmet Blend dry cat food sold at Wal-Mart locations in Connecticut, Delaware, Massachusetts, Maryland, Maine, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, Vermont, and West Virginia. The pet food is being voluntarily recalled following a positive test result indicating a potential contamination with Salmonella.

Recalls and Safety Alerts: Serious Hypersensitivity Reactions with Abacavir (Ziagen)
FDA is alerting healthcare professionals that certain patients are more likely to experience serious and potentially fatal hypersensitivity reactions when treated with the antiretroviral drug abacavir. Abacavir is sold under the trade name Ziagen an...

FDA Requires Stronger Fungal Infection Warning for TNF Blockers
FDA has told the makers of drugs known as "tumor necrosis factor alpha blockers" (TNF-alpha blockers) to strengthen existing labeling.

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.

The Hartz Mountain Corporation Voluntarily Recalls One Specific Lot of Nationwide Chicken-Basted Rawhide Chips Because of Possible Health Risk (October 20)
The Hartz Mountain Corporation, Secaucus, NJ is voluntarily recalling one specific lot of Hartz Chicken-Basted Rawhide Chips due to concerns that one or more bags within the lot are potentially contaminated with Salmonella. Hartz is fully cooperating with the US Food and Drug Administration in this voluntary recall.