RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > FDA Warns Canadian API Manufacturer Following Adverse Event Reports

FDA Warns Canadian API Manufacturer Following Adverse Event Reports

Posted 09 December 2015 | By Zachary Brennan 

FDA Warns Canadian API Manufacturer Following Adverse Event Reports

After reports of serious adverse events surfaced for patients administered drug products compounded with an active pharmaceutical ingredient (API) from Quebec-based Medisca Pharmaceutique, the US Food and Drug Administration (FDA) inspected the company’s Pittsburgh-based site and found that the APIs were actually mislabeled and misbranded.

During the inspection in February 2014, investigators collected six samples of APIs labeled as L-Citrulline that Medisca repackaged for distribution to pharmacies for use in compounding.

“FDA laboratory analysis of these samples determined that two of the samples were N-Acetyl-Leucine, a different amino acid,” the agency says, noting that the use of “subpotent L-Citrulline and product incorrectly labeled as L-Citrulline in patients with certain urea cycle defects can lead to high ammonia levels, which is serious and potentially life-threatening.”

The company later recalled eight lots of the L-Citrulline product after Medisca’s own testing indicated that they did not contain L-Citrulline. But FDA is now calling for more details on the company’s investigation into the extent of the product mix-up and how other APIs distributed, or will be distributed, are not impacted. 

FDA is also taking issue with the fact that Medisca has not categorized L-Citrulline as an API, even though the company “repackaged, relabeled and distributed L-Citrulline to compounding pharmacies and hospitals that, you were informed, used this product as a bulk drug substance in compounding drugs for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals.” 

The agency also says it received information indicating that Medisca may be repackaging and distributing domperidone API to pharmacies for use in compounding drugs, even though domperidone is not the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph and is not a component of an FDA-approved drug.

“If you are repackaging and distributing the API domperidone you should stop immediately,” FDA says.

And this warning letter isn’t the first time Medisca has had problems with FDA and other US law enforcement for mislabeling.

In 2011, the company and its president, Antonio Dos Santos (which is who this recent warning letter is addressed to), each pleaded guilty to the misdemeanor charge of introducing a misbranded drug, specifically the human growth hormone somatropin, into interstate commerce using misleading labeling.

According to a consent order from the Maryland Board of Pharmacy, Medisca bought the human growth hormone from a manufacturer in China and then distributed the drug to pharmacies throughout the US, claiming from March 2005 to November 2007 that the drug was “FDA approved” and/or from “an FDA-approved facility” And although FDA had assigned a National Drug Code number to osmatropin, the drug was never approved for commercial distribution by FDA.

The company and Dos Santos paid $15,000 in fines and forfeited more than $1 million in gross profits from unlawful drug sales. The company did not respond to a request for comment.

Warning Letter

March 15, 2012: Sentencings in Human Growth Hormone Distribution Case


Regulatory Focus newsletters

All the biggest regulatory news and happenings.