D-1144-2023 Class III Terminated
FDA drug recall D-1144-2023 was initiated by Caplin Steriles Limited on August 14, 2023 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated September 9, 2025). Affected quantity: 19, 820 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- September 13, 2023
- Initiation Date
- August 14, 2023
- Termination Date
- September 9, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19, 820 vials
Product Description
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
Distribution Pattern
Nationwide in Tennessee
Code Information
Lot #: 90000228