Past Recalls for Acetaminophen Manufacturer

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November 09, 2006 1:50 PM

Michigan-based pharmaceutical firm Perrigo Inc., which today issued a massive recall of its store brand pain-relief drug acetaminophen after tests revealed metal particles in nearly 400 batches sold in Wal-Mart, Target and CVS among others, has previously been forced to pull similar drugs off shelves because of false labeling.

According to complaints filed by the Federal Trade Commission, in late 2001 Perrigo's "Made in the USA" labels on acetaminophen products were "false and misleading," and in 2005 a confusing dosing syringe, which came with infant droplets, led to a similar drug recall program.

The company operates facilities in China, Mexico, Germany and Israel but hinted today that a third party supplier was responsible for the dangerous manufacturing error.

A 2001 FTC complaint stated that Perrigo had "represented, expressly or by implication that certain of its aspirin, acetaminophen, and ibuprofen products are made in the United States...In truth and in fact, a significant portion of the ingredients of certain of respondent's aspirin, acetaminophen, and ibuprofen products is, or has been, of foreign origin." Perrigo's labeling of its products in this manner apparently constituted "unfair or deceptive acts," according to the FTC.

The company agreed in a consent order to repackage these products, and the FTC issued its final complaint about false labels in February 2002.

In July 2005, cherry-flavored infant droplets containing acetaminophen were also recalled by Perrigo, according to the FDA, because mistaken dosages, which could have resulted from the confusing dosing syringes, could have proven dangerous to very young children.

The company has not returned a call seeking information about the manufacturing origin of today's 383 recalled acetaminophen batches and the previous FTC complaints but issued a press release designed to calm consumers and investors.