I wanted to share this important information with my community, blogger viewers, and twitter friends. The U.S. Food and Drug Administration (FDA), has issued a recall of 43 children’s medications available over the counter, issued late Friday.
The FDA is recommending that parents throw away any of the products having lot numbers specified on the FDA website. There are over 1000 lot numbers listed on the site. The FDA is suggesting the use of generic equivalents of the products.
Johnson and Johnson’s McNeil Consumer Healthcare unit in Fort Washington, Pa. manufactured all of the recalled products.
The affected products are Children’s Tylenol, Children and Infants Motrin, Children’s Benadryl and Children’s Zyrtec. The FDA has stated that an inspection of the McNeil manufacturing facility uncovered broken equipment, heavy dust and grime, duct taped pipes and a hole in the ceiling. The FDA also found product ingredients contaminated by bacteria, products containing larger amounts of active ingredients than specified, inactive ingredients that did not meet testing requirements and small metallic particles in some products.
The FDA cited poor quality control procedures and inefficient employee training as problems.
Johnson and Johnson was denying that consumer complaints had lead to the inspection and subsequent recall but the FDA states that over 50 such complaints were received concerning dark spots in some of the liquid medicines.A poor response to these complaints by Johnson and Johnson has been added to shortcomings noted by the FDA at the McNeil plant. This recall is specific to liquid products produced at McNeil Consumer Healthcare in Washington, Pa. and chewable products and tablets for children produced by Johnson and Johnson are said to be
safe.
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