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

"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 at Brigham and Women's Hospital.

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

Click HERE to see the FDA's report.

The company and the FDA issued the voluntary recall of certain over-the-counter 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 news release on the company's website.

The recall is the drugmaker's third in the past eight months directly related to quality problems. In December, certain arthritis medications and other products were pulled from the market after reports of an "unusual moldy, musty, or mildew-like odor" and cases of gastrointestinal illness linked to the consumption of the products.

A number of pediatric liquid products were recalled in December because of concerns over the quality of an inactive ingredient that is a component of the drugs.

Recall Affects Drugs That Came Under Fire Previously

"Speaking as a parent and a pharmacologist, the frequency of these recalls does not foster great confidence in the manufacturing standards for these medicines in that they are being released before quality testing is completed," said Dr. David Kroll, professor of pharmaceutical sciences at North Carolina Central University in Durham. "I was struck in particular by the comment from the FDA that parents consider substituting generic versions of the child medicines, rather than use adult-strength medicines."

Another potential problem is that the recall affects the same category of medications that came under fire from an FDA advisory committee in 2007.

"The FDA nonprescription drug advisory committee [at the time] found that there was little to no compelling evidence that cough and cold medications are efficacious in children under 6, and they may pose a meaningful risk," said Dr. William Shrank of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital and a member of the FDA OTC drug advisory panel.

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