On June 15, 2017, Advanced Pharma, Inc. recalled all unexpired lots of Nitroglycerin products that were produced at Advanced Pharma’s Houston location between March 3, 2017, and May 31, 2017. The recall was 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 recalled all unexpired lots of Nitroglycerin.
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 patients who have not responded to nitroglycerin tablets taken under the tongue and other heart medicines; and to lower blood pressure during surgery.
Although nitroglycerin is titrated based on clinical response, an extreme and unexpected reduction in dose could lead to a delay in treatment, disruption of clinical care of the patient, and worsening of the 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. The recalled products are packaged in various sizes per carton. These products were not distributed directly to patients or consumers, but rather to health care facilities (e.g., hospitals) nationwide between March 9, 2017, and June 1, 2017. The recalled products have expiration dates ranging from June 9, 2017, to August 15, 2017.
See the FDA Safety Alert
See the Recall
See also Medical Law Perspectives Report: Mending a Broken Heart: Malpractice Risks in Diagnosing and Treating Heart Disease
See also Medical Law Perspectives Report: Congenital Heart Conditions: How Infants, Adults, and Healthcare Providers Handle the Risks
See also Medical Law Perspectives Report: Diagnosis and Treatment of Heart Attacks: Liability Issues
See also Medical Law Perspectives Report: Under Pressure: Liability Risks in Diagnosing and Treating Glaucoma