Children's Tylenol is still off the shelves at my neighborhood pharmacy, evidence that the problems that caused 6 million bottles of children's medicines made by Johnson & Johnson's McNeil division to be recalled on April 30, including Motrin, Benadryl, and Zyrtec, haven't been solved. Situation still not normal.
Many of the recalled medicines had excessive amounts of the active ingredients, raising the risk of overdose and poisoning. But so far there's no evidence that children have been harmed by the bad medicines, the Food and Drug Administration reported yesterday to a congressional committee that is investigating the massive recall.
But officials at J&J and McNeil didn't act quickly to investigate and solve quality problems with their children's medicines, despite the fact that other recalls last fall—and the FDA's inspection in April that prompted the latest recall—made it clear that the companies' factories weren't meeting quality standards.
That's not the only problem. For instance, the September 2009 recall, sparked by concern over bacterial contamination, didn't include all the medications at risk of being tainted, the FDA report said. In addition, the company didn't move to improve quality control after almost 50 people complained of specks, metal, or other foreign material in medicines in 2009 and 2010, according to the FDA. That means many families may still have tainted children's medicines in the medicine cabinet.
This latest unsettling situation is a good reminder that we all need to check our medicine cabinets, and throw out children's medicines in the suspect lots. To find out which medications have been recalled, or to request a refund for medicine in your home, visit McNeilProductRecall.com or call 1-888-222-6036. The FDA recommends that parents buy generic children's medications until investigations are complete. (Quality control problems with medications are a growing issue for both prescription and over-the-counter drugs, as I reported back in 2007.) Or consider non-drug alternatives to relieve children's cold symptoms.
Tomorrow J&J boss Colleen Goggins, who is worldwide chairman of the company's consumer group, is scheduled to testify before the House Oversight and Government Reform Committee on the massive pediatric medication recall, as are FDA officials. It will be interesting to see if they have any assurances to offer to parents on the safety of children's medicines aside from, "Oops, sorry."