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.

Unlock this article by subscribing to STAT Plus and enjoy your first 30 days free!


What is it?

STAT Plus is a premium subscription that delivers daily market-moving biopharma coverage and in-depth science reporting from a team with decades of industry experience.

What's included?

  • Authoritative biopharma coverage and analysis, interviews with industry pioneers, policy analysis, and first looks at cutting edge laboratories and early stage research
  • Subscriber-only networking events and panel discussions across the country
  • Monthly subscriber-only live chats with our reporters and experts in the field
  • Discounted tickets to industry events and early-bird access to industry reports

Leave a Comment

Please enter your name.
Please enter a comment.

Sign up for our Daily Recap newsletter

A roundup of STAT’s top stories of the day in science and medicine

Privacy Policy