FDA criticizes manufacturer for slow reaction to consumer complaints ,,
FRIDAY, Jan. 15 (HealthDay News) -- 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.
According to McNeil, it is possible that the TBA leeched into the packaging material and then into the products themselves.
While Autor commended the company for broadening its recall to include products that consumers have not complained about, she chastised them for acting too slowly to report and investigate the probl
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