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FDA Expands Probe of McNeil Consumer Healthcare

May 18, 2010 | Parker Waichman LLP

The Food & Drug Administration (FDA) is expanding its probe of Johnson & Johnson’s McNeil Consumer Healthcare following last month’s recall of more than 40 children’s over-the-counter medicines. That recall was the third issued by McNeil since last September.

According to The Wall Street Journal, the FDA is looking into manufacturing across the entire McNeil unit. The agency wants to make sure there weren’t any similar manufacturing problems and to identify any steps the agency must take to prevent the problems from recurring. McNeil Consumer Healthcare has plants in Fort Washington and Lancaster, PA, as well as Las Piedras, Puerto Rico.

The McNeil recall issued last month was due to concerns the drugs might contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. The medications – 43 varieties of Tylenol Infant Drops, Children’s Tylenol Suspensions, Children’s Tylenol Plus Suspensions, Motrin Infant Drops, Children’s Motrin Suspensions, Children’s Zyrtec Liquid in Bottles, and Children’s Benadryl Allergy Liquid in Bottles – were recalled in the U.S. and 11 other countries.

The FDA cited deficiencies at the company’s Fort Washington, PA facility that could have caused bacterial contamination of raw materials in the recalled products. The agency also charged that McNeil knowingly used bacteria-contaminated materials to make the recalled drugs. The FDA’s report on the Fort Washington facility cited more than 20 manufacturing problems, including not properly testing for contamination of the recalled products. The agency also faulted McNeil for failing to initiate corrective action after receiving 46 consumer complaints from June 2009 to April 2010 regarding foreign materials in the drugs.

McNeil has since closed the Fort Washington plant until it fixes the issues and can assure quality production. According to the Journal , the FDA has begun to review all complaints it has received to determine whether the recalled products caused any serious side effects. An FDA spokesperson told the Journal there had been no specific complaints about products from other McNeil facilities.

In September, McNeil recalled more than 50 children’s and infants’ Tylenol products after the bacteria Burkholderia cepacia (B. cepacia) was detected in an “inactive ingredient” in products manufactured between April and June 2008.

In November, the company recalled 5 lots of Tylenol Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP following consumer reports of a musty odor, which was associated with nausea, stomach pain, vomiting and diarrhea. That recall was expanded in December to include all lots of the Tylenol Arthritis Pain Caplets. The same recall was expanded yet again in January to include various lot of Tylenol, Rolaids, Benedryl and St. Joseph’s Aspirin. In total, the expanded recall included about 50 million bottles of the medications.


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