Johnson & Johnson has expanded its recall of over-the-counter medications, the second time the company did so in less than a month. It was because of a moldy smell that has made users sick. The broadening recall now includes some batches of regular and extra-strength Tylenol, children’s Tylenol, eight-hour Tylenol, Tylenol arthritis, Tylenol PM, children’s Motrin, Motrin IB, Benadryl, Rolaids, Simply Sleep and St. Joseph’s aspirin. Caplet and geltab products sold in the Americas, the United Arab Emirates, and Fiji were recalled. Johnson & Johnson’s McNeil Consumer Healthcare Products recalled some Tylenol Arthritis Caplets in November due to the smell, which caused nausea, stomach pain, vomiting and diarrhea. Three weeks prior, the company had expanded its recall to include Tylenol Arthritis Caplets.
The FDA says McNeil did not act fast enough on the recalls. McNeil knew of the problem in early 2008 but made only a limited investigation. The agency said about 70 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.”
The FDA sent McNeil a warning letter for violating manufacturing standards and failing to report and investigate the problem in a timely way. The FDA says it wants an explanation as to why the problem was not made public sooner. A full list of the recalled products is online at www.mcneilproductrecall.com.
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