FDA Issues Warning Letter to McNeil on Recalled Products

FDA has issued a warning letter to McNeil Healthcare stating that its Jan. 8 inspection of the company's Las Piedras, Puerto Rico, location identified significant cGMP violations. Since 2008, McNeil has received odor complaints regarding certain Tylenol products. In 2009, McNeil began recalling bottled OTC products after discovering that packaging may have been contaminated with a pallet pesticide. The recall now numbers 60 million bottles.

These violations, which included the failure to thoroughly investigate consumer complaints of a "moldy smell" emanating from certain OTC products, caused certain drug products to be adulterated, FDA wrote. In addition, "the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with CGMP regulations," the agency wrote.

During a press conference on Friday, FDA representatives explained that while the agency was first notified in September 2009 of the consumer complaints, McNeil had started receiving such complaints in early 2008 and discovered a trend to them in September 2008.

Noting that McNeil has voluntarily increased its product recall well beyond the lots for which it received complaints, FDA contends that McNeil should have "acted faster," said Deborah Autor, director of the Office of Compliance (OC) in FDA's Center for Drug Evaluation and Research (CDER).

Drug manufacturers "have a corporate responsibility to ensure that products are of high quality, safe, and effective. If something smells bad, companies must be aggressively investigate," Autor said. "When a problem arises, manufacturers must be proactive, quick, and thorough to ensure quality, safety, and effectiveness."

McNeil believes the source of the contamination to be the presence of the chemical 2,4,6 Tribromoanisole (TBA), a known degradant of 2,4,6, Tribromophenol (TBP). TBP is a pesticide and flame retardant used to treat wooden pallets for transporting packaging materials and finished product. It is theorized that one of the chemicals leached into packaging components stored in these pallets, reported Karen Hirshfield, acting branch chief, Recalls and Shortages Branch, OC, CDER.

FDA is looking into whether other manufacturers may be using TBP to treat pallets, Autor reported.

In the warning letter to McNeil, FDA wrote that the "initial investigation into the root cause of the odor was unjustifiably delayed and terminated prematurely. Numerous complaints were received over a four month period in 2008 before they were considered a trend and before actions were initiated to determine the root cause. When microbiological testing in August 2008 did not support an initial speculation that microbial contamination was the root cause of the odor, the investigation was closed. No other possible root causes were pursued. Your firm lacked adequate justification for this decision."

McNeil has 15 working days of receipt of the letter to respond. The warning letter can be viewed here.