Recall of Nitroglycerin Injection in 5% Dextrose USP by Advanced Pharma due to sub-potency

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ISSUE: Advanced Pharma, Inc. d/b/a Avella of Houston (“Advanced Pharma”) is voluntarily recalling all unexpired lots of Nitroglycerin products that were produced at Advanced Pharma’s Houston location between March 3, 2017 and May 31, 2017 to the hospital/user level. The recall is being issued based on laboratory test results indicating a lower than expected potency on certain lots of compounded NitroGlycerin Injection which would lead to a lower dose being administered. While the lower than expected potency results affected only certain lots of Nitroglycerin, Advanced Pharma is recalling all unexpired lots of NitroGlycerin. To date, Advanced Pharma has not received any reports of product complaints and/or adverse events related to the products.

Although nitroglycerin is titrated based on clinical response, an extreme and unexpected reduction in dose than expected could lead to a delay in treatment, disruption of clinical care of the patient, and worsening of patient’s conditions.

The recalled NitroGlycerin products include the 100 mcg per mL and 200 mcg per mL strengths available in 5 mL, 10 mL, and 20 mL sterile single dose syringes and are packaged in various sizes per carton. These products were not distributed directly to patients or consumers, but rather to healthcare facilities (e.g. hospitals) nationwide in the USA between March 9, 2017 to June 1, 2017 and have expiration dates ranging from June 9, 2017 to August 15, 2017. The issue is segregated to the Houston location and no other Avella locations are involved or affected.

BACKGROUND: Nitroglycerin Injection in 5% Dextrose, USP is indicated for treatment of high blood pressure before, during or after surgery; for control of heart failure after a heart attack; for treatment of heart related chest pain in patient...

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