Children's Tylenol, Motrin, Zyrtec, Benadryl Recall 2010: FDA Reports Horrendous Conditions at McNeil Facility

The FDA inspection of the McNeil Consumer Healthcare facility in Fort Washington, Pennsylvania has revealed that filthy conditions, safety violations and lack of proper controls by staff may have led to the recall of over 40 Children's Tylenol, Motrin, Zyrtec and Benadryl medications. The hygiene and safety violations have lead the FDA to begin an investigation of McNeil's manufacturing practices company-wide. The FDA report is shocking to say the least.

In April 2010, FDA inspectors found multiple problems at the McNeil plant that produces Children's Tylenol, Motrin, Zyrtec and Benadryl medications, including bacterial contamination and filthy equipment. McNeil was notified of FDA findings, but did not take any action and the problems persisted, eventually leading to the recall of Children's Tylenol, Motrin, Zyrtec and Benadryl. In all, the FDA found 20 violations. There were "problems with almost every system in the plant."

At the McNeil facility, FDA inspectors found filthy conditions including "incubators with a large amount of visible gray and brown dust/debris, large holes in the ceiling and thick dust covering the grill inside a filtered cabinet." There were also layers of "thick dust and grime" found by FDA inspectors throughout the plant. The FDA found ingredients used in making Children's Tylenol, Motrin, Zyrtec and Benadryl that were tainted with bacteria. The bacteria were later confirmed to be Burkholderia cepacia (B.cepacia).

B.cepacia is a bacteria found naturally in soil, water and rotting vegetation. It can survive and flourish in moist environments and is resistant to many antibiotics. B.cepacia can be very difficult to treat and it can even survive in betadine, a common antiseptic. B.cepacia is not a threat to healthy adults, but can lead to a fatal lung infection in people with compromised immune systems, infants, children, the elderly and people with lung disease. B.cepacia was the same bacteria responsible for the December 2009 recall of Children's Tylenol medications. It is not known how B.cepacia contaminated ingredients for Children's Tylenol, Motrin, Zyrtec and Benadryl medications or why it was still present in the McNeil plant following the 2009 incident. Other contaminates have also been detected at the plant, but have not yet been identified. The FDA inspection report reveals that McNeil knew that some of the raw materials used to manufacture Children's Tylenol, Motrin, Zyrtec and Benadryl were contaminated with bacteria but chose to use them anyway.

The FDA also found that some Children's Tylenol, Motrin, Zyrtec and Benadryl medications were overly concentrated. In a congressional memo, the medications were said to have "the potential to be superpotent" and possibly cause overdose in children. According to the FDA, the McNeil plant "does not maintain adequate laboratory facilities for the testing and approval (or rejection) of components of drug products" used to manufacture Children's Tylenol, Motrin, Zyrtec and Benadryl. There were few quality control measures in place, and those that were were not followed properly. Another problem: a large percentage of McNeil staff was comprised of temporary workers who were not properly trained. After McNeil began receiving consumer complaints about black particles in some Children's Tylenol, Motrin, Zyrtec and Benadryl medications, they did no internal investigation and continued production at the McNeil plant.

The McNeil plant in Pennsylvania is the only facility in the U.S. that manufactures children's versions of Tylenol, Motrin, Zyrtec and Benadryl. It has remained closed since late April. The facility will not resume manufacture of Children's Tylenol, Motrin, Zyrtec and Benadryl medications until the plant is cleared by the FDA. Given the current hearings before the House Committee on Oversight and Government Reform, it could be quite a long time before McNeil gets FDA clearance.

Currently ALL liquid and drops formulations of Infants' and Children's Tylenol, Motrin, Zyrtec and Benadryl have been recalled. For a complete list of recalled medications see Children's Tylenol, Motrin, Zyrtec, Benadryl Recall 2010 Expanded. Johnson & Johnson and the FDA assure parents that chewable tablets and pill forms of Children's Tylenol, Motrin, Zyrtec and Benadryl are safe to consume.

For More Information About the Children's Tylenol, Motrin, Zyrtec, Benadryl Recall 2010 See the Following Articles:
Congress to Hold Hearing May 27
Congressional Memo Reveals Bacterial Contamination Dates to 2009
Congressional Panel to Investigate Recall of Children's Medications
How to Request a Refund from McNeil Consumer Healthcare
Children's Tylenol, Motrin, Zyrtec, Benadryl Recall 2010 Expanded

Sources
The Injury Board
Wikipedia: Burkholderia cepacia Complex
Examiner.com
Reuters