Tainted Painkillers: How Dangerous?

Unlike the e-coli-tainted spinach that sickened 200 people and caused three deaths this fall, this week’s metal-tainted acetaminophen outbreak appears to have harmed no one. Even so, the Perrigo Company, the world’s largest manufacturer of generic over-the-counter drugs, isn’t taking any chances. At a cost of a reported $2.9 million, the company has voluntarily recalled 11 million bottles of the generic painkiller it makes for such retailers as Wal-Mart, CVS, and Dollar General. Perrigo is cautioning that the pills could contain fragments of metal after trace amounts were found in some of its 500-milligram caplets.

According to the Food and Drug Administration (www.fda.gov), the problem came to light last week after Perrigo quality control measures revealed issues with manufacturing equipment. After sweeping 70 million pills with metal detectors, Perrigo inspectors found 200 caplets that contained pieces of metal ranging from 1-millimeter “microdots,” to 8-millimeter pieces of wire. A Perrigo executive said of the recall, “We are taking this measure to maintain the highest possible product quality standards for our retail customers and their store-brand consumers.”

Thus far, no injuries have been reported. The FDA has categorized the adverse health impact of the recall as remote because both the percentage of tainted pills potentially on the market and the adverse side effect of ingesting one of them appears to be relatively small.  “Even if you did ingest one of these tainted caplets, you might experience some minor stomach discomfort and maybe a small cut in the mouth or throat,” said FDA spokeswoman Kristen Neese.

This is Perrigo’s third acetaminophen-related recall in five years. Last summer, it voluntarily recalled an infant oral-drop product because the enclosed dosing syringe wasn’t marked to accurately measure the acetaminophen dosage. And in 2001, Perrigo cooperated with the FDA by recalling nearly 8,000 bottles of cherry-flavored pain reliever medicine when it was determined that the bottles contained almost 30 percent more than the labeled amount of acetaminophen. The Michigan-based company manufactures generic, store-name brands of over-the-counter drugs for more than 100 retailers and wholesalers including  Costco, CVS, Dollar General, Kroger, Safeway, Sam’s Club, Wal-Mart and Walgreens.

As for this recall, NEWSWEEK had no problem purchasing a bottle of tainted pills from a Manhattan CVS after the drugstore retailer said it had placed a block on its entire point-of-sale system to prevent sales of the tainted bottles of CVS-brand acetaminophen tablets. When told of this, a CVS official stated that the block would be in place by the end of Thursday.