Ingredients used by Johnson & Johnson in some of the 40 varieties of children’s cold medicines recalled last week in the US and 11 other countries were contaminated with bacteria, according to a report by the US Food and Drug Administration.
However, none of the company’s finished products tested positive for the contaminants, though such testing is not definitive, officials said.
“We think the risk to consumers at this point is remote,” said Deborah Autor, director of FDA’s drug compliance office.
Last week’s sweeping recall is the latest quality issue to taint J&J’s over-the-counter medicine franchise. In January, the company recalled a line of adult Tylenol pain relievers due to complaints of a moldy smell associated with wooden pallets used to transport the drugs.
The FDA report lists more than 20 manufacturing problems found at the McNeil Consumer Healthcare plant in Pennsylvania, where formulas were made. The recalled products include children and infant formulations of Tylenol, Motrin, Zyrtec and Benadryl.
The company did not have laboratory facilities to test drug ingredients and failed to follow up on customer complaints, FDA inspectors said.
J&J called the problems cited by the FDA “unacceptable to us.” The company said production at the plant won’t resume until problems are fixed.