Over-the-Counter medications subject of expanded recall

Johnson & Johnson has expanded a recall of over-the-counter medications, marking the third time it has done so since a November 2009 recall notice was issued. The  recall resulted from complaints about a moldy or musty smell and medications that have made users sick.

Originally reported by the Federal Drug Administration, the expanded recall now includes some batches of regular and extra-strength Tylenol Children’s Tylenol, eight-hour Tylenol, all lots of Tylenol Arthritis 100-count with ez-open red cap, Tylenol PM, Children’s Motrin, Motrin IB, Benadryl, Rolaids, Simply Sleep, and Saint Joseph’s Aspirin. Caplet and geltab versions of the products sold in the Americas, the United Arab Emirates and Fiji were covered in the recall. In November, Johnson & Johnson’s McNeil Consumer Healthcare Products issued a recall of some Tylenol Arthritis Caplets due to a moldy or musty smell, which caused nausea, stomach pain, vomiting and diarrhea. In December, the company expanded  the recall to include Tylenol Arthritis Caplets. The manner in which the company has handled the recall has drawn the ire of federal regulators. The Food and Drug Administration complained that McNeil was aware of the problem in early 2008 but only conducted a limited investigation. The agency reported about seventy people were either sickened by the odor or noticed it.

“McNeil should have acted faster,” said Deborah Autor, the director of the FDA’s Office of Compliance of the Center for Drug Evaluation and Research. “When something smells bad, literally or figuratively, companies must aggressively investigate and take all necessary action to solve the problem.” McNeil was issued a FDA warning letter, citing it for violating manufacturing standards and failing to report and investigate the problem in a timely way, according to Autor. Johnson & Johnson was given 15 days to respond.

The FDA says it wants an explanation of why the problem was not made public sooner. According to McNeil, there have been no reports of nausea related to the most recent recall.  However the company did state the expanded recall includes product lots that could be affected by the same problems of nausea. A full list of the recalled products is online at www.mcneilproductrecall.com and http://www.tylenol.com/page2.jhtml?id=tylenol/news/subp_tar_recall.inc. Johnson & Johnson said the smell is caused by small amounts of a chemical associated with the treatment of wooden pallets.

The FDA said the chemical can leach into the air, and traced it to a facility in Las Piedras, Puerto Rico. The New Brunswick, N.J., company said it is investigating the issue and will stop shipping products with the same materials on wooden pallets. It has asked suppliers to do so as well. The company said it is working with the Food and Drug Administration. Also on Friday, Federal prosecutors in Boston said Johnson & Johnson paid tens of millions of dollars in kickbacks so nursing homes would put more patients on its blockbuster schizophrenia drug. The company gave special rebates to Omnicare Inc., the country’s biggest company providing pharmacy services to nursing homes, in return for recommendations from its pharmacists that patients use Risperdal.