February 8, 2012

News

What IS the FDA Doing? More Problems with Generic Kids’ Medicines

Cheree Cleghorn | May 26, 2010

One expert quoted in the full story asked what the FDA is doing about pre-market quality control.

Following FDA advice to parents to search for generic children’s medicines after Johnson and Johnson’s recall of many of their products, a generic company manufacturer has been found to have the same kinds of contamination problems.

Where is a mother to turn? What brand should a father reach for at the drug store?

In addition to this news, a related story today discloses problems with herbal dietary supplements, which also contain contaminants and in some instances are sold illegally as “cures” for serious medical problems.

The right question is what is the FDA doing, period.

The New York Times

“For consumers who turned to drugstore house brands after the recall last month of liquid children’s Tylenol and other medicines made by a unit of Johnson & Johnson, there is yet more unsettling news.

“The recall included more than 40 varieties of liquid pediatric Tylenol, Motrin, Benadryl and Zyrtec that may have contained metal particles, too much of the active drug ingredient or inactive ingredients that did not meet testing requirements. At the time, the Food and Drug Administration recommended that consumers look for generic alternatives to these brand-name over-the-counter drugs. (Emphasis added)

“But now, Perrigo, a company based in Michigan that supplies drugstore equivalents of those children’s medicines to pharmacy chains like CVS and Walgreens, has received a warning letter from the F.D.A. about significant manufacturing violations of its own — including ibuprofen tablets contaminated with metal shavings. (Emphasis added)

Although the problems cited in the warning letter did not mention children’s products, the deficiencies at both Johnson & Johnson and Perrigo raise questions about why some manufacturing plants have shipped defective medicines.” (Emphasis added)

Source: New York Times, March 26, 2010

Topics: News

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