Recalls / Class III
Class IIID-1144-2023
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
- Brand name
- Milrinone Lactate
- Generic name
- Milrinone Lactate
- Active ingredient
- Milrinone Lactate
- Route
- Intravenous
- NDCs
- 72485-501, 72485-502, 72485-503
- FDA application
- ANDA214380
- Affected lot / code info
- Lot #: 90000228
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Caplin Steriles Limited
- Manufacturer
- Armas Pharmaceuticals Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 895 & 897 Survey No, N/A, Gummidipoondi, N/A N/A, India
Distribution
- Quantity
- 19, 820 vials
- Distribution pattern
- Nationwide in Tennessee
Timeline
- Recall initiated
- 2023-08-14
- FDA classified
- 2023-09-06
- Posted by FDA
- 2023-09-13
- Terminated
- 2025-09-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1144-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.