Tylenol batch recalled due to strange smell

By Dr. Ananya Mandal, MDOct 18 2010

Johnson and Johnson’s (J&J) commonly used over-the-counter painkiller Tylenol has been recalled again in some batches because of complaints of a musty or moldy odor in the product. The company is facing a U.S. congressional probe of quality control lapses in the past as well. The drugs recalled to date include the painkiller Motrin and allergy treatment Benadryl as well as this batch of 100,000 bottles of Tylenol.

A company spokeswoman revealed that the batch is question was adult Tylenol eight-hour caplets sold in 50-count bottles in the United States and Puerto Rico. She also informed that this recalled batch was made in March at a factory in Fort Washington, Pennsylvania, operated by J&J's McNeil Consumer Healthcare unit. J&J shut down the McNeil plant the following month and is upgrading the facility to correct quality control lapses discovered by U.S. Food and Drug Administration inspectors.

The FDA in its report said that there is dust and grime at the manufacturing unit that contaminated ingredients. J&J plans to reopen the plant next year, and is using other McNeil plants to help offset lost production of the recalled products. The plant makes products that have annual sales of about $650 million, about 1 percent of total annual company sales.

Last of the biggest recalls was on January 15^th 2009 that included 53 million bottles of Tylenol, Motrin and antacid Rolaids because of musty or moldy odors. The smell was attributed to a chemical called 2,4,6-tribromoanisole present in wooden pallets that transport and store product packaging materials. This fresh recall will hurt third quarter earnings informed the company.