FDA found bacteria in lots for recalled Tylenol
Wed, 05 May 2010 10:30:25 GMT —
Federal health regulators say Johnson & Johnson managers failed to test for contamination of more than 40 varieties of children's cold medicines recalled over the weekend .
An inspection report released Tuesday by the Food and Drug Administration lists more than 20 manufacturing problems found at the Fort Washington, Pa., plant where the formulas were produced. The recalled products include children and infant formulations of Tylenol, Motrin, Zyrtec and Benadryl.
FDA inspectors visited the plant in mid-April and wrapped up their inspection Friday. J&J issued its "voluntary" recall later that night.
Among other problems, FDA inspectors said the company did not have laboratory facilities to test drug ingredients and failed to follow up on customer complaints.
The FDA previously said serious medical problems with the products are unlikely, but advised consumers to stop using the medicine as a precaution.
J&J's McNeil Consumer Healthcare unit said some of the recalled medicines may have a higher concentration of the active ingredient than listed on the bottle. Others may contain particles, while still others may contain inactive ingredients that do not meet testing requirements.
The sweeping recall, which involved products sold in the U.S. and 11 other countries, 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.