The FDA isn't happy with the conditions at the Fort Washington, Pennsylvania, factory that produced the children's Tylenol, Motrin, Benadryl, and other over-the-counter drugs that were recalled last weekend.
According to an FDA inspection report posted on Tuesday, McNeil Consumer Healthcare (Johnson & Johnson) knowingly used bacteria-contaminated materials to make kids' medicine.
The FDA said it's considering a wide range of actions, including possible criminal penalties.
McNeil Consumer Healthcare released a statement regarding the FDA inspection report, saying it has temporarily suspended production at the plant (the company's only one that manufactures all of its liquid pediatric drugs), and adding:
"While the chance of serious adverse medical reaction is remote, we apologize to those who rely on our medicines for the concern and inconvenience this recall may have caused. We will provide a detailed response to the FDA on their observations, and work diligently to ensure that they are addressed."
Stephen Byrn, founder of Purdue University's pharmacy quality compliance program, told USA Today that although he doesn't doubt that the risk of health problems from the recalled lots is remote, the type and scope of manufacturing problems cited by FDA inspectors make it difficult to have confidence in the plant's products.
The FDA urges parents not to use these products and recommends choosing private label alternatives.
If you have questions about the recall, go to McNeil Product Recall or call 888-222-6036.
Also check out How to Get a Refund for Recalled Children's Tylenol and other medicine.
Have you lost your faith in kids' medicine manufacturers?