The U.S. Food and Drug Administration has sent a warning letter to drug distributing giant McKesson Corp. for allegedly shipping pharmacies opioid products with pills missing or non-opioid replacements.
The agency documented several alleged incidents when the company shipped tampered opioid products, stemming from what it found during inspections of McKesson's corporate headquarters and a distribution center.
In its warning letter, the agency cites the company for allegedly failing to sufficiently respond, quarantine and investigate shipments of oxycodone hydrochloride sent to three Rite Aid pharmacies in 2016 after McKesson had been notified about the tampering issues.
McKesson is the first firm to receive a warning letter from the FDA under the Drug Supply Chain Security Act, which set new tracking requirements for drug manufacturers, repackagers and wholesale distributors.
"This is simply unacceptable," FDA Commissioner Dr. Scott Gottlieb said in a statement Tuesday. "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."
Rite Aid alerted McKesson in September 2016 that one of its Michigan pharmacies received a bottle that was supposed to contain 100 oxycodone tablets, but it contained 15 tablets of naproxen sodium, the common over-the-counter pain reliever marketed as Aleve. McKesson received a second notification from Rite Aid that same month about a similar incident in another pharmacy. A third incident was reported in October, where three out of five oxycodone bottles had naproxen sodium and ciprofloxacin hydrochloride, a common antibiotic.
FDA said in its warning letter that the oxycodone had been replaced when McKesson was in control of the packages. The agency also cited other incidents involving tampered medications for HIV, seizures, bipolar disorder and high blood pressure.
In response to the allegations, McKesson spokeswoman Kristin Chasen said the company has been in communication with the FDA and they are providing additional information to the agency.
"McKesson takes this situation very seriously," Chasen said. "We are committed to the security of the supply chain and are taking steps to help ensure we comply fully with FDA's track-and-trace laws for all pharmaceutical products."
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