Advanced Pharma Inc. d/b/a Avella of Houston is recalling all unexpired lots of Nitroglycerin Injection 5% Dextrose USP products due to a lower than expected potency. The recalled products were produced at their Houston location between March 3 and May 31, 2017.
The recalled products include the 100mcg per mL and 200mcg per mL strengths available in 5mL, 10mL, and 20mL sterile single dose syringes. They were distributed to healthcare facilities nationwide between March 9 and June 1 and have expiration dates ranging from June 6 to August 15, 2017.
Nitroglycerin Injection is indicated for treatment of peri-operative hypertension; for control of congestive heart failure in the setting of acute myocardial infarction; for treatment of angina pectoris in patients who have not responded to sublingual nitroglycerin and ß-blockers; and for induction of intraoperative hypotension.
Although the issue of lower than expected potency only affects certain lots, the company is recalling all unexpired lots out of an abundance of caution. To date, there have been no reports of product complaints and/or adverse events concerning the product. Healthcare facilities who received the products have been notified. Use of the recalled medications should be immediately discontinued, with unused portions sent back to Avella.
Adverse events or quality complaints may be reported to the Food and Drug Administration (FDA)’s MedWatch Adverse Event Reporting program.
For more information visit Avella.com.