Amid regulatory concerns over counterfeit medicines, one of the largest U.S. wholesalers failed to follow proper procedures after being notified by customers that illegitimate products had been shipped, according to a recent inspection by the Food and Drug Administration.
Specifically, McKesson (MCK) failed to identify and then quarantine “suspect or illegitimate” products. The wholesaler also did not retain samples or promptly notify other customers there was reason to believe illegitimate products were shipped. The inadequate procedures did not name specific products or types of products, but were noted in a so-called 483 report after an FDA inspection this past June and July.
The FDA report did not specifically mention counterfeit drugs. In fact, the FDA report raises broader questions about whether McKesson has procedures in place for handling the recall of any medicine, legitimate or otherwise.
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