Second Major Recall for J&J—FDA Found Manufacturing Violations in Children’s OTC Drugs

In a recent blog, our Washington D.C. Pharmacy Error Attorneys discussed the U.S. Food and Drug Administration’s (FDA) push for a broad recall of over-the-counter (OTC) products by Johnson & Johnson (J&J) in January—in an effort to maintain the health and safety of the consumer and to prevent OTC medication errors, after customers complained of moldy, musty smells in the drugs, that were caused by trace amounts of a chemical used when shipping the products.

The FDA announced this week that the administration has pushed J&J to begin another recall of certain children’s OTC liquid medicines—because of reported manufacturing deficiencies and violations found by federal health regulators during a routine inspection at a drug facility in Washington Pa—that could affect the quality, purity and potency of the products.

According to the FDA and the J&J unit, McNeil Consumer Healthcare, consumers should stop using all unexpired lots of both children’s and infant’s Tylenol, Zyrtec, Benedryl, and Motrin, because some the drugs reportedly may contain a larger concentration of the active drug than specified on the package. The recall also includes products that may contain inactive ingredients, other potentially solidified product ingredients, or other manufacturing residues that could include particles like tiny metal specks—that may not meet the testing requirements.

McNeil stated although there is only a remote possibility for serious medical problems, consumers should stop using the drugs, to avoid personal injury or illness in children.

McNeil has posted a full list of the recalled products on its website and is currently investigating the plant where the products were created to make sure that there are no other problems, that could cause medication error or consumer injury with the OTC drugs. This is the second major recall this year for J&J and McNeil.

Lebowitz and Mzhen, LLC represent victims of medication mistakes the Washington, D.C. area. Contact our attorneys today for a free consultation.

Children’s Tylenol and Other Drugs Recalled, The New York Times, May 1, 2010
McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children’s Products, PR Newswire, April 30, 2010
Tylenol Recall: FDA Slams Company, CNN Money, January 15, 2010

Related Web Resources:

U.S. Food and Drug Administration: (FDA)

McNeil Product Recall Information

Contact Information