Tuesday, January 19, 2010

Over the Counter Drug Recall

J&J issues recall of over-the-counter drugs.
The New York Times (1/17, Singer) reported that "McNeil Consumer Healthcare, a division of Johnson & Johnson, announced the recall of several hundred batches of popular over-the-counter medicines" after "receiving consumer complaints about moldy-smelling bottles of Tylenol Arthritis Relief caplets." According to a warning letter from the FDA, the move "came 20 months" after the company "began receiving the complaints." Consumers have since "also reported temporary digestive problems like nausea, vomiting, and stomach pain, the agency said."
The AP (1/18) reported that the recall "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." The products include "caplet and geltab products sold in the Americas, the United Arab Emirates, and Fiji." The odor "is caused by small amounts of a chemical associated with the treatment of wooden pallets, [J&J] said."
CQ HealthBeat (1/16, Norman) reported that the FDA "criticized McNeil Consumer Healthcare for failing to act more quickly to expand" the recall following consumer complaints. The warning letter from the agency cited "multiple violations of current good manufacturing practice requirements, and said the company didn't report quality problems to the agency." The Wall Street Journal (1/16, Favole, Dooren) also covered the story.

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