FDA Investigation Findings for Infant and Children’s Medicine Recall
The Food and Drug Administration inspection report for the McNeil Consumer Healthcare manufacturing facility involved in the recall of over 40 over-the-counter medications for infants and children was released Tuesday.
The company’s quality control department was found deficient in many aspects. One observation of the inspectors was that “raw material lots had known contamination with gram negative organisms and were approved for use to manufacture several finished lots of Children’s and Infant’s Tylenol drug products, which remain within expiration date(s) on the market.” Another observation showed a failure on the company’s part to ensure proper dosage of products such as Infants’ Dye-Free Tylenol Suspension Drops. The company also failed to follow up on “46 consumer complaints regarding foreign materials, black or dark specks from June 2009 to April 2010.”
If you or a loved one has been injured by a defective product, contact Houston product liability lawyer, Brian Jensen.
