Zydus Recall Verapamil Hydrochloride for Cross Contamination

Zydus Pharmaceuticals (USA) Inc initiated recall of multiple lots of Verapamil Hydrochloride injection due to potential cross contamination with other products. Verapamil Hydrochloride is a calcium channel blocker medication used for the treatment of high blood pressure, angina. The drug products are manufactured by Zydus LiveScience Ltd, India.

Zydus facility at Jarod (FEI 3013712903), India was recently classified as OAI (official action indicated) following an inspection at the facility by USFDA in April 2024. The inspection was conducted by USFDA investigators Justin A Boyd and Anastasia M Shields. One of the critical observations in the inspection was cross contamination issues due to cleaning deficiencies of equipment and investigation and impact assessment  was not thorough in evaluating all impacted batches.

USFDA Enforcement Report