Advanced Pharma Recalls Nitroglycerin Products

June 16, 2017

The company is voluntarily recalling all unexpired lots of nitroglycerin products produced at its Houston location for potency issues.

On June 15, 2017, Advanced Pharma, Inc. d/b/a Avella of Houston announced it is voluntarily recalling all unexpired lots of nitroglycerin products produced at its Houston location from March 3, 2017–May 31, 2017 to the hospital level. The recall is in response to potential problems with product potency and is limited to the company’s Houston location.

According to the company, laboratory test results indicated a lower than expected potency on certain lots of nitroglycerin. Advanced Pharma has not received any reports of adverse events as of June 15 but is recalling all unexpired lots out of caution. A reduced dose could interrupt a patient’s treatment, according to the company.

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 packaged in various sizes per carton. These products were distributed to healthcare facilities nationwide in the United States between March 9, 2017 to June 1, 2017 and have expiration dates ranging from June 9, 2017 to August 15, 2017.

Customers should return unused product to Avella. Adverse events can be reported to FDA at www.fda.gov/medwatch/report.htm.

Source: FDA