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McNeil Recalling Hundreds of Lots of Contaminated OTC Medications
FDA Criticizes Manufacturer for Handling of Investigation
By News Staff
A complete list of affected products and lot numbers can be found online.
McNeil said in a Jan. 15 news release that it has received consumer complaints of moldy, musty or mildew-like odor that, in some cases, was associated with temporary and nonserious gastrointestinal events, including nausea, stomach pain, vomiting or diarrhea.
The manufacturer said the products contain trace amounts of a chemical called 2,4,6-tribromoanisole, a degradant of 2,4,6-tribromophenol, which is a fungicide and flame retardant used to treat wooden pallets. The company's action follows a voluntary recall in December of Tylenol Arthritis Relief caplets based on the same complaint.
Although McNeil said reported adverse events have not been serious, the FDA leveled harsh criticism at McNeil and its parent company Johnson & Johnson in a warning letter dated Jan. 15.
The FDA said in the letter that an inspection of a McNeil facility in Puerto Rico completed Jan. 8 identified "significant violations of the current good manufacturing practice regulations for finished pharmaceuticals." The agency added that McNeil failed to submit alert reports after becoming aware of problems.
The manufacturer was cited for "failure to thoroughly investigate any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed."
"In addition," said the agency, "(McNeil) failed to extend the investigation to other batches of the same product and other products that might have been associated with the discrepancy as required."
The FDA also criticized parent company Johnson & Johnson for not taking appropriate action to resolve problems at McNeil.
The agency urged McNeil to promptly correct the violations cited in its letter and warned that failure to do so could result in legal action without further notice, including seizure. McNeil has 15 working days from its receipt of the letter to notify the FDA in writing of the specific steps it has taken to correct violations.