FDA Raised Concerns About Tylenol Plant in 2003Jun 24, 2010 | Parker Waichman LLP
A Pennsylvania factory operated by Johnson & Johnson’s McNeil Consumer Healthcare unit had problems going back as far as 2003, according to a CNN investigation. The facility manufactured dozens of recently recalled children’s and infant’s over-the-counter medicines.
That April 30 recall included more than 40 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. At the time, the company said some 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.
That recall was just one of five McNeil has issued for its cold and pain relief products over the past eight months
McNeil has temporarily shut down production at the Fort Washington, PA facility where the drugs were manufactured. In April, the U.S. Food & Drug Administration (FDA) cited more than 20 manufacturing problems, including not properly testing for contamination of the recalled products. The problems prompted the FDA to widen its investigation of McNeil’s manufacturing practices, and it is now inspecting the company’s other facilities in Lancaster, PA and Puerto Rico. Officials from the agency have also said they were considering possible criminal charges against Johnson & Johnson and McNeil.
According to CNN, the Pennsylvania plant was having issues long before the April recall. For example:
• An FDA inspection report from December 2003 noted a mislabeling problem related to some lots of children’s soft-chew Tylenol. The report said the packages of the product listed an incorrect amount of an ingredient per tablet. The affected product were destroyed and relabeled the products that had not yet been released into the market. However, no recall was issued.
• In January 2006, FDA inspectors noted that some equipment used to make drugs had not been properly cleaned.
• A February 2008 report listed more serious problems, such as insufficient follow-up and investigation of consumer complaints.
• In May 2009, inspectors highlighted deficiencies including incomplete investigations into contamination of raw materials.
What’s more, months prior to the April recall, the FDA pushed McNeil to remove some infant’s and children’s Motrin products from the market after an inspection of the Fort Washington facility in early February raised concerns that the drug maker had not adequately tested a batch of raw materials that was used to make them. According to CNN, McNeil told the FDA that it was satisfied with its own testing, and that it had proceeded to make the Motrin drugs and did not bother to test the finish products.
The FDA lead inspector was clearly concerned that the Motrin products were allowed to stay on the market, writing in the report that “the potential for contamination of the entire lot remains a possibility.” The report further stated that “the most appropriate corrective action would have been to get control of all finished product.”
While the FDA can recommend a recall, it does not have the authority to force one unless the product poses potential for serious injury or death.