Milrinone Lactate Injection — Class III drug recall D-1144-2023
Terminated recall by Caplin Steriles Limited, reported 2023-09-13, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-1144-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Caplin Steriles Limited, Gummidipoondi, N/A, India |
| Recall initiated | 2023-08-14 |
| Classified | 2023-09-06 |
| Reported by FDA | 2023-09-13 |
| Terminated | 2025-09-09 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 72485-0501, 72485-0501-01, 72485-0501-10, 72485-0502, 72485-0502-01, 72485-0502-10, 72485-0503, 72485-0503-01 |
| Lot numbers | 90000228 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1144-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.