Plant Manufacturing Children’s Medicine Cited for Quality Control and Contamination Issues

The plant that manufactures Children’s Tylenol and Motrin has been cited by the FDA for quality control and contamination issues. The Fort Washington PA plant owned by McNeil Consumer Healthcare, the sole plant that manufactures such popular over-the-counter children’s drugs, used raw materials contaminated with bacteria. In addition to the bacteria contamination, the FDA noted that plant officials failed to respond to consumer complaints that black particles were found in some of the children’s medicines. The FDA is considering taking further action against McNeil for the plant deficiencies.
According to the Washington Post, “The findings are serious,” said Deborah M. Autor, a senior official at the Food and Drug Administration, which documented 20 problems at the Fort Washington, Pa., plant owned by McNeil Consumer Healthcare, a division of Johnson & Johnson.
Last week McNeil announced a voluntary recall of 43 over-the-counter pediatric medicines including Children’s Tylenol, Motrin, and Benadryl. The recall may affect 70% of the market for children’s over-the-counter drugs.
In its 10 day inspection of the plant, the FDA cited McNeil for failure to train employees, failure to track consumer complaints, a failure to spot trends that suggest a systemic deficiency, and a lack of written protocols.