FDA Drug recall D-1144-2023
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, Dis…
- FDA Drug
- Class III
- terminated
- Published 2023-09-13
On 2023-09-13 the FDA classified a Class III recall of 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, Dis… by Caplin Steriles, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1144-2023 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2023-08-14 |
| Published | 2023-09-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Caplin Steriles |
| Distribution | US |
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
Failed Impurities/Degradation Specifications
Identifiers
| ndc | 72485-501-01 |
|---|---|
| ndc | 72485-501-10 |
| ndc | 72485-502-01 |
| ndc | 72485-502-10 |
| ndc | 72485-503-01 |
| code_info | Lot #: 90000228 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1144-2023%22
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