Two Drugs Recalled Due to Manufacturing Issues

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By Mark Rubinshtein

(December 13, 2021) Two pharmaceutical companies have issued recalls in December due to manufacturing issues that may impact the safety and quality of their drug products.

Edge Pharma issued a voluntary recall for all drug products produced in its FDA-registered 503B outsourcing facility in Colchester, VT.  Edge stated that products were removed as a result of “process issues” that may have impacted the sterility of its drug products.  The recall includes a wide variety of sterile products.  These include lidocaine, vancomycin, norepinephrine, and methotrexate, as well as a number of non-sterile products.  The use of non-sterile drug products that are intended to be sterile may result in serious, possibly fatal, infections.

Also this month, Teligent, Inc. issued a voluntary worldwide recall on two lots of their topical lidocaine solution due to superpotency.  The two lots had been distributed throughout the United States.  Superpotent lidocaine can be dangerous to patients and has the potential to cause systemic toxicity leading to hypotension, brachycardia, and possible cardiovascular collapse. In October, the New Jersey company issued a similar recall in connection with five lots of topical lidocaine solution.

Fortunately, no adverse events related to the December recalls by either Edge or Teligent have been reported.

Mark Rubinshtein
Mark Rubinshtein's practice focuses on patent litigation and prosecution for clients in the chemical and pharmaceuticals industries. Dr. Rubinshtein earned his J.D. at University San Diego School of Law. Prior to law school, Dr. Rubinshtein obtained a B.A in Chemistry and M.S. in chemical engineering from Columbia University and completed his PhD in organic chemistry in 2011 at UC San Diego. His graduate work focused on developing targeted small molecular therapeutics for Alzheimer's disease and on devising synthetic methods for the preparation of side-chain functionalized biodegradable and biocompatible polymers.
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