FDA to Probe Children’s Cold, Allergy Medicine Recall

Saturday, May 01, 2010

WASHINGTON —  The Food and Drug Administration says it is investigating after a health-care company recalled more than 40 over-the-counter infant’s and children’s liquid medications.

McNeil Consumer Healthcare issued the voluntary recall late Friday in the United States and 11 other countries after consulting with the FDA. The recall involves children’s versions of Tylenol, Tylenol Plus, Motrin, Zyrtec and Benadryl, because they don’t meet quality standards.

In a statement Saturday, the FDA says it was reviewing procedures at McNeil. The company is based in Fort Washington, Pa., and appears to be the sole source of the problems.

The FDA says the potential for serious medical problems is “remote,” but it is advising consumers to stop using the medicine.

Some of the products recalled may have a higher concentration of active ingredient than is specified on the bottle. Others may contain particles, while still others may contain inactive ingredients that do not meet internal testing requirements.

The company is advising consumers to stop giving the products to their children as a precautionary measure. The recall was not undertaken because of any adverse effects, the company said.

The medicines were made and distributed in the United States, and exported to Canada, the Dominican Republic, Dubai, Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad and Tobago and Kuwait.

Details, including NDC numbers, are available by phone at 1-888-222-6036 or on the Web at www.mcneilproductrecall.com.