Last month, the Food and Drug Administration Commissioner recommended that consumers switch to generic brand medicines in the wake of Johnson & Johnson’s recall of over 136 million medicine bottles, including liquid children’s Tylenol, Motrin, Benadryl and Zyrtec. Now, consumers may have to find yet another medicine alternative, because the FDA has issued a warning letter to Perrigo Co. for quality-control violations, including its failure to detect metal shaving contaminants in its ibuprofin batches.
Perrigo and Johnson & Johnson comprise 90 percent of the market for children’s liquids, and Perrigo is the world’s largest supplier of generic, store-branded non-prescription medications, with clients like CVS and Walgreens. Four years ago, the company recalled pills that contained pieces of wire that were as long as eight millimeters.
The warnings issued to Johnson & Johnson, and now Perrigo, have increased suspicions that the drug industry’s quality-control mechanisms are more inadequate and long-standing than previously reported.
Last month, the House Committee on Oversight and Government Reform
opened up an investigation into the recalled Johnson & Johnson products, which contained more active ingredients than necessary, inactive ingredients or infection-causing bacteria.
Today, Committee Chairman Edolphus Towns (D-N.Y.) expanded the scope of the committee’s investigation by asking for all Johnson & Johnson records related to the company’s 2008 Motrin recall, in which it instructed contractors to buy Motrin off the shelves instead of publicly announcing a recall.
On Thursday, an FDA official stated that McNeil Consumer Healthcare, the J&J subsidiary responsible for the recalled products, may face criminal charges, product seizures or other sanctions. The FDA said it has referred the case to its office of criminal investigation, which works in conjunction with the Justice Department to prosecute companies.
As it stands, the FDA is not empowered to require drug recalls; companies may only voluntarily recall problematic drugs. Perrigo is based in Michigan, which is the only state in the nation that prohibits its own residents from suing drug companies.
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