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Safety

Johnson & Johnson Recalls OTC Drugs

Product Safety: Expanded recall by McNeil division follows warning letter from FDA

by Michael McCoy
January 19, 2010

After receiving a harsh warning letter from FDA, Johnson & Johnson's McNeil Consumer Healthcare division has expanded its recall of over-the-counter drugs in the Americas, the United Arab Emirates, and Fiji.

 The recall involves Tylenol, Motrin, Benadryl, and other consumer products manufactured at a McNeil facility in Las Piedras, Puerto Rico. It follows consumer complaints of a musty, moldy, or mildew-like odor that, in some cases, was associated with gastrointestinal disturbances.

McNeil says it has determined that the smell is caused by trace amounts of 2,4,6-tribromoanisole, a chemical that can result from the breakdown of 2,4,6-tribromophenol, a pesticide and flame retardant used to treat wooden shipping pallets. In addition to initiating the recall, McNeil says it is requiring suppliers that ship materials to its plants to discontinue use of the pallets.

The expanded recall, announced Jan. 15, follows more limited ones in November and December, both related to the same unusual smell. The FDA warning letter, also dated Jan. 15, takes McNeil to task for not acting more quickly to determine the root cause of the odor after it first started receiving complaints in 2008.

"We are aware of the complaint information available to your company, the sequence of events, and the extent of your firm's follow-up measures during this period," the letter states. "We have concluded that your company did not conduct a timely, comprehensive investigation."

In particular, the agency faults the company for not expanding the scope of its investigation after determining, in October 2009, that one variety of Tylenol was exposed to the treated pallets. McNeil notes that its latest recall action was voluntary and taken in consultation with FDA.

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