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FDA Warns Medisca About Adulterated Drug Products

Dec. 9, 2015, 9:50 PM

The FDA told Canada-based Medisca Pharmaceutique Inc. that a portion of its active pharmaceutical ingredients (APIs) are adulterated, according to a warning letter posted Dec. 8 on the agency’s website.

The Food and Drug Administration said its investigators inspected Medisca’s facility in Plattsburgh, N.Y., in 2014 after receiving reports of serious adverse events in patients who were administered drug products compounded using the firm’s API labeled as L-Citrulline.

During this inspection, the investigators collected six samples of APIs labeled as L-Citrulline that were repackaged by Medisca for distribution to compounding pharmacies, the FDA said. Subsequent laboratory analyses determined that two ...