Drug 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
D-1144-2023
Product summary
- Event
- Event 92900
- Status
- Terminated
- Classification
- Class III
- Quantity
- 19, 820 vials
- Official record key
drug-enforcement:D-1144-2023
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: 90000228
Distribution pattern: Nationwide in Tennessee
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications