Federal officials have sent a warning letter to Johnson & Johnson for not acting quickly to take products off drugstore shelves after a moldy smell prompted a voluntarily recall of Tylenol Arthritis. The recall now includes Motrin, Benadryl, Rolaids, St. Joseph's aspirin, and other name brands.
As a Johnson & Johnson subsidiary expanded its recall of some of its over-the-counter drugs on Friday, federal health officials said a warning letter has been sent to the company for failing to act quickly to take the products off the shelves after customers were sickened by a moldy smell on the medications.
"This morning, McNeil Consumer Healthcare voluntarily expanded its recall of over-the-counter drugs to include approximately 500 lots of products," Deborah M. Autor, director of the Office of Compliance in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, said during a morning teleconference Friday.
The company's recall started last September and was limited to certain lots of Tylenol, although that recall was expanded in December. The recall now includes certain lots of Motrin, Benadryl, Rolaids and St. Joseph aspirin.
To date, there have been some 70 reports from consumers about the problem, and in some cases using these products has resulted in nausea, stomach pain, vomiting and diarrhea, Autor said.
The company believes the contamination was caused by a chemical used to treat the wooden pallets on which packaging material is transported and stored. The chemical, 2,4,6-tribromoanisole (TBA) also occurs naturally and has been blamed for giving wine a moldy taste.
"The health effects of this chemical have not been well-studied, but no serious events have been documented in the medical literature," Autor said.
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