Product: Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC 72485-502-01 (single vial), Rx only, Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728(USA) Manufactured by: Caplin Steriles Limited, India, NDC 72485-502-10
Reason for recall: Failed Impurities/Degradation Specifications
Recall initiated: 20230814
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated