The FDA Warned This Major Drug Maker for Allegedly Shipping “Illegitimate” Opioid Products

Drug distributor McKesson has received a warning letter from the Food and Drug Administration (FDA) for allegedly shipping “illegitimate” opioid products.

This marks the first time that the FDA has issued a warning letter under the 2013 Drug Supply Chain Security Act.

According to the FDA’s allegations, McKesson failed to identify, investigate and stop people from tampering with its opioid shipments.

Some of the bad shipments had been discovered in Michigan at three Rite Aid pharmacies. It was in September and October of 2016 that the pharmacies reported receiving bottles oxycodone hydrochloride that were instead filled with naproxen and in one case, a combination of naproxen and ciprofloxacin hydrochloride, the FDA said.

“A distributor’s failure to have systems in place to investigate and quarantine suspect and illegitimate products within their control is a violation of the law. But this is even more concerning given that we’re in the midst of a widespread opioid crisis,” stated FDA Commissioner Scott Gottlieb.

“This is simply unacceptable,” Gottlieb said.

McKesson has 15 days from the time it receives the letter to outline the steps it has taken to correct the violations that were flagged by the FDA and to identify and conduct investigations related to other reports of suspicious or illegitimate shipments. The letter was dated February 7th.

Disclaimer: We have no position in McKesson Corporation (NYSE: MCK) and have not been compensated for this article.