The voluntary temporary shut-down came as the Food & Drug Administration gave more details about the production problems that sparked the move of 40 varieties of children's cold and allergy medicines. The FDA says the plant cannot re-open until it notifies the agency, and the FDA agrees it is safe.
Federal health regulators say managers of the plant, owned by Johnson & Johnson, failed to test for contamination of raw ingredients used in those over-the-counter medicines.
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.
And it noted that the FDA had been trying for more than a year to get McNeil to correct production problems.
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 some manufacturing equipment was covered with dust, and others was held together by duct tape. The company did not have laboratory facilities to test drug ingredients. The agency says its inspectors found bacterial contamination in some raw materials. They declined to name the type of bacteria, saying they "didn't have enough information in yet."
The FDA says there is no indication of contamination in the finished products.
The FDA previously said serious medical problems with the products are unlikely, but advised consumers to stop using the medicine as a precaution.
Agency officials today reiterated that advice, and warned parents not to give adult versions of Tylenol, Motrin, Zyrtec, or Benadryl products to children.
In a telebriefing, the agency says McNeil also failed to follow up on 46 consumer complaints over the past year.
When it recalled the products late Friday, 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.
Agency officials say they will further evaluate the inspectors' report, and may take further action against McNeil. While they wouldn't be specific, they said their "tools" include fines, direct orders, and criminal action.
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.
The full list of recalled products can be found at <"http://www.mcneilproductrecall.com/">www.mcneilproductrecall.com.