Metal-tainted acetaminophen outbreak appears to be the latest in a series of outbreaks this fall. However no one appears to have been harmed. Still Perrigo Company, the world's largest manufacturer of generic over-the-counter drugs is not planning on taking any chances. At a cost of $2.9 million, the company has reportedly voluntarily recalled 11 million bottles of the generic painkiller it made for retailers like CVS, Wal-Mart, and Dollar General. Perrigo has cautioned users that the pills could contain fragments of metal after trace amounts were found in some of its 500-milligram caplets.
The Food and Drug Administration reported that the problem came to light only last week after Perrigo quality control measures revealed issues with manufacturing equipment. When sweeping around 70 million pills with metal detectors, Perrigo inspectors found that 200 caplets contained pieces of metal ranging from 1-millimeter 'microdots', to 8-millimeter pieces of wire. Describing the recall a Perrigo executive said, 'We are taking this measure to maintain the highest possible product quality standards for our retail customers and their store-brand consumers.'Injuries have not been reported so far. According to the FDA the adverse health impact of the recall is remote because both the percentage of tainted pills that potentially exists on the market as well as the adverse side effect of ingesting one of them appears to be relatively small. FDA spokeswoman Kristen Neese said, '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.'
This has been Perrigo's third acetaminophen-related recall in five years. Last summer, it made a voluntary recall of its infant oral-drop product because the enclosed dosing syringe wasn't marked to accurately measure the acetaminophen dosage. In 2001, Perrigo cooperated with the FDA by recalling nearly 8,000 bottles of cherry-flavored pain reliever medicine when it found that the bottles contained almost 30 percent more than the labeled amount of acetaminophen.
A CVS official stated that the block would be in place by the end of Thursday.
Source-Medindia
NLA
