Federal investigators say McNeil Consumer Healthcare, a division of Johnson & Johnson, used contaminated Tylenol ingredients in some children’s liquid medications that were recalled last week.
The FDA released a report of investigator findings (pdf) on Tuesday, saying that raw materials used in the making of the products affected by the children’s drugs recall had “known” contaminants, but were used anyway. Inspectors said that the plant’s quality control unit should have kept the contaminated Motrin, Tylenol, Benadryl and Zyrtec ingredients out of children’s medications, though the contaminants have not yet been found in finished products.
The liquid children’s medication recall was announced by McNeil and FDA on Friday. About 1,500 lots of medication were recalled due to problems at McNeil’s Fort Washington, Pennsylvania, plant, including:
- Concentrated Tylenol Infants’ Drops
- Children’s Tylenol Suspension
- Children’s Tylenol Plus Suspension
- Concentrated Motrin Infants’ Drops
- Children’s Motrin Suspension
- Children’s Zyrtec
- Children’s Benadryl Allergy
Although no problems have been reported in association with the recalled medications and the risk of serious medical problems is low, parents throughout the United States and 11 other countries have been urged to stop using the medications. In addition to the possibility of contamination by organisms, some of the products may have higher concentrations of active ingredients than are specified, others may contain inactive ingredients that do not meet internal testing requirements and some may contain tiny particles, according to the FDA.
The FDA has received 46 consumer complaints of black or dark specks and foreign material in the liquid medications between June 2009 and April 2010. Investigators said they found some areas of one plant used to manufacture the drugs covered in a thick layer of dust and grime. For the time being, the FDA is urging parents to use generic versions of the drugs.
Parents have been asked to report any adverse reactions or quality problems experienced with the use of these products through the MedWatch website at www.fda.gov/medwatch. If any unexpected symptoms have occurred after use of any of the recalled products, parents should contact their health care provider.
McNeil is offering coupons good for future purchase or a refund for products affected at their website www.mcneilproductrecall.com or by calling 1-888-222-6036.