·  Legal News, Analysis, & Commentary

Recalls & Safety Alerts

FDA Sends Warning Letters to Opioids Repackers

— July 18, 2019

The FDA sends warning letters to opioid repackers.

The FDA announced it issued warning letters to three companies that repackage opioids –Asclemed USA Inc., doing business as Enovachem, B&B Pharmaceuticals Inc., and Spectrum Laboratory Products Inc. – for “significant violations” of current good manufacturing practice requirements.

According to a press release, the warning letter to Enovachem pointed out “failure to acquire and hold onto documents with the identity of the original manufacturer and certificates of analysis from the original manufacturer…The company also distributed active pharmaceutical ingredients, including opioids, to its customers, without complete certificates of analysis.”

The FDA also indicated that B&B Pharmaceuticals neglected to “thoroughly investigate complaints regarding sub-potent active pharmaceutical ingredients, and did not perform cleaning validation studies to show that its cleaning procedures for nondedicated production equipment are sufficient to prevent potential cross-contamination between repackaged active pharmaceutical ingredients, including highly potent drugs such as opioids, testosterone, progesterone and estrogen.”  It also “failed to provide adequate certificates of analysis for active pharmaceutical ingredients,” the agency said.

Photo by Samuel Zeller on Unsplash

Spectrum “did not provide all the required information in its certificates of analysis that it provided to its customers, including compounding pharmacies, and did not properly investigate and resolve critical current good manufacturing practice deviations, including damaged bottles of repackaged opioids.”

Spectrum’s and Enovachem’s warning letters said further the companies listed glycerin as one of the products they repackage, and more than a decade ago, the FDA issued an alert that warned of the “potential public health hazard of glycerin tainted with diethylene glycol,” a poison.

“The FDA remains vigilant in our inspections and oversight of the supply chain and as part of this effort, we inspect active pharmaceutical ingredients repackers to help identify and prevent any weaknesses in the legitimate supply chain.  This is especially important within the context of the opioid crisis for those who handle opioids,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said, adding, “The supply chain issues we have found in the active pharmaceutical ingredients repacking industry broadly pose a real threat to the public health and we’re calling on them to address these issues as quickly as possible.”

Each company has must submit responses to the agency, and any failure to correct the violations could result in “limitation, seizure and injunction,” the FDA said.

These warnings followed letters sent regarding the use of kratom as a way to discontinue opioid use.  The agency issued warnings to KratomNC and Cali Botanicals before following up to alert consumers to the dangers of the drug.  The well-known, negative side-effects associated with kratom include nausea, dizziness, drowsiness, breathing suppression, coma and even death.  The FDA has also linked kratom-based products with a multi-state salmonella outbreak.  The latest warning urges consumers not to use products made KratomNC, because of microorganisms found in the products which can lead to illness.  Kratom is also addictive, so using it to eliminate opioid use simply swaps one addictive drug for another.

Other letters sent to opioid repackers included warnings sent to Vipor Chemicals Private Ltd., Lumis Global Pharmaceuticals Co. Ltd., Sal Pharma, Huron Pharmaceuticals Inc. and Fagron Inc.

Editor’s note: While we appreciate reader comments, particularly those that open meaningful discussion, the comments on this post have become just shy of abusive. Therefore, we regret that comments on this post have been closed.


FDA warns repackers distributing pharmaceutical ingredients, including opioids, for putting consumers at risk with significant violations of manufacturing quality standards

FDA and Kratom

FDA issues warnings to companies that claim an herbal drug can cure opioid addiction

Join the conversation!