More than 40 varieties of infant and children’s liquid Tylenol, Motrin, Benadryl and Zyrtec were recalled late Friday because of manufacturing deficiencies that may affect the quality, purity or potency of the over-the-counter medications. The recall involves all unexpired lots (see the recall notice for a complete list).
According to the Food and Drug Administration, some of the products included in the recall may contain a higher concentration of active ingredient than specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles.
“We want to be certain that consumers discontinue using these products and that they know what to do if they have concerns about a specific product,” said FDA Commissioner Margaret A. Hamburg, M.D. “While the potential for serious health problems is remote, Americans deserve medications that are safe, effective and of the highest quality. We are investigating the products and facilities associated with this recall and will provide updates as we learn more.”
This is McNeil’s second major recall of children medication. In September the company recalled 21 types of infants’ and children’s liquid Tylenol because it may have been contaminated with bacteria.
The recalled medicine should not be used. Concerned consumers can contact the company at 1-888-222-6036 and also at www.mcneilproductrecall.com. The FDA advises parents and caregivers who are not sure about alternative pediatric health treatment options to talk to their doctor or pharmacist and reminds them not to give drug products to infants and children that are not intended for those age groups as this could result in serious harm.
Our take: Tylenol’s response to the adulteration case in 1982, in which seven people in the Chicago area died, became a business school example of good corporate behavior. But with two big recalls in less than a year, something has gone awry. Good corporate behavior seems to have been supplanted by bad manufacturing processes and a lack of quality control. We look forward to seeing the results of the FDA’s investigation.
[Via – Consumer Reports]
