Children's Tylenol Recall Result of 'Abundance of Caution': FDA

May 4, 2010— -- An "abundance of caution" led to last week's product recall by Tylenol maker McNeil Consumer Healthcare, a U.S. Food and Drug Administration spokeswoman said. But drug safety experts said that serious or not, the episode proves that not just generic drugs can fall victim to quality control problems.

"This recall provides compelling evidence that quality assurance is an issue for all drugmakers, and is not specific to generic products, as many have implied," said Dr. Jerry Avorn, professor of Medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women's Hospital.

"This shows that the problem isn't generic versus brand, but good manufacturing practices versus sloppy manufacturing practices," said Merrill Goozner, a freelance writer and independent consultant to consumer groups. "The FDA needs more money to police the entire drug manufacturing supply chain, brand name and generic, over-the-counter or prescription."

The company and the FDA issued the voluntary recall of certain over-the-counter (OTC) children's and infants' liquid products after consumer complaints of "tiny particles" in the medicines, as well as the possibility that some of the medications "may contain a higher concentration of active ingredient than is specified" and "others may contain inactive ingredients that may not meet internal testing requirements," according to a press release on the company's Web site.

The recall affects a total of 43 different products sold under the brand names of Tylenol, Motrin, Zyrtec and Benadryl.

Thus far, there is no indication as to which medications of those recalled are linked to each of the problems cited in the company's press release.