Children's Tylenol Recall: FDA Report Rips Quality Control at Plant

Posted on May 8, 2010 in Health & Wellness

Regulators Can’t Rule Out Further Action Against Company


Post a Comment By DAN CHILDS

May 5, 2010

aw materials used to make children’s liquid cold medications subject to an April 30 recall were contaminated with bacteria, according to a U.S. Food and Drug Administration report released Tuesday.

FDA inspection finds contaminated raw materials used to make child meds.The recall affected 43 different Johnson & Johnson products sold under the brand names of Tylenol, Motrin, Zyrtec and Benadryl.

Preliminary tests have only narrowed down the possible bacterial contaminant to a category of microorganism described as “gram negative,” a broad group that includes many germs potentially harmful to humans. No injuries or illnesses have been reported in relation to the recalled products, and the FDA has said that despite finding the bacterial contaminants in the raw materials used to make the drugs, tests have yet to reveal any of the finished product to be similarly contaminated.

The report also suggested that raw material with “known contamination with gram negative organisms” were used to manufacture several finished lots of Children’s and Infant’s Tylenol drug products.