Tylenol Recall Leads to Bigger Headaches

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The Food and Drug Administration announced Monday that it is expanding its search of Johnson and Johnson’s (Stock Quote: JNJ ) McNeil Consumer Healthcare following its investigation of the Fort Washington, Pa., plant responsible for a recent recall of children’s Tylenol.

On May 1, McNeil voluntarily issued a recall of about 40 versions of its children’s Tylenol, Motrin, Zyrtec and Benadryl products. The FDA subsequently confirmed that the medications coming for the Fort Washington facility were contaminated with bacteria.  It released a 17-page inspection report detailing its findings on May 6, citing 20 health code violations.       

“The FDA is conducting a company-wide investigation of McNeil Consumer Healthcare’s drug manufacturing practices to determine whether similar problems exist throughout the company and what additional steps the agency must take to ensure that these problems do not recur,” the FDA said on its Web site.

The FDA’s findings could result in criminal penalties. It has not disclosed how many McNeil facilities will be involved in the extended probe. McNeil also has plants in Lancaster, Pa. and Las Piedras, Puerto Rico.

During its initial inspection, conducted from April 19 to April 30, the FDA found that the Fort Washington plant did not conduct proper quality control procedures or maintain adequate lab facilities. It also cited that “control procedures used did not validate the manufacturing processes that caused variability in the characteristics of the drug product,” meaning that certain products may have contained too much of an active ingredient.   

Additionally, the report states that McNeil failed to respond to customer complaints, saying “no corrective preventative action was initiated for 46 consumer complaints regarding foreign materials, black or dark specks from June 2009 to April 2010.”

Johnson and Johnson has since shut down the Fort Washington facility. Following the FDA’s announcement of the company-wide investigation, a spokesperson for McNeil told CNN that the company “continues to cooperate with the FDA."

But the FDA isn’t McNeil’s only problem. The House Committee on Oversight and Government Reform, alarmed by the FDA’s report and McNeil’s failure to respond to consumer complaints, is also investigating the recall. The congressional committee required McNeil to turn over its previously undisclosed records of the complaints by yesterday. An investigative hearing is scheduled on May 27.

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