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.
Edge, potency, recall, sterility, superpotency, Teligent, voluntary
By using this blog, you agree and understand that no information is being provided in the context of any attorney-client relationship. You further agree and understand that nothing herein is intended to be legal advice. This blog is solely informational in nature, and is not intended as, and should not be used as, a substitute for competent legal advice from a retained and licensed attorney in your state. Knobbe Martens LLP makes no representations or warranties as to the accuracy, completeness, timeliness or availability of the information in this blog. Knobbe Martens LLP will not be liable for any injury or damages relating to your use of, or access to, any such information. Knobbe Martens LLP undertakes no obligation to correct or update information on this blog, which may be incorrect or become incorrect or out of date over time. Knobbe Martens LLP reserves the right to alter or delete content or information on the blog at any time. This blog contains links and references to other websites and publications that you may find of interest. Knobbe Martens LLP does not control, promote, endorse or otherwise have any affiliation with any other websites or publications unless those websites or publications expressly state such an affiliation. Knobbe Martens LLP further has no responsibility for, and makes no representations regarding, the content, accuracy or any other aspect of the information in such websites or publications.