MILRINONE LACTATE Recall D-1144-2023
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
MILRINONE LACTATE Recall D-1144-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1144-2023 |
| Event ID | 92900 |
| Brand | MILRINONE LACTATE |
| Generic Name | MILRINONE LACTATE |
| Manufacturer | MILRINONE LACTATE |
| Original Package? | 1 |
| Active Substance | MILRINONE LACTATE |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide in Tennessee |
| Quantity | 19, 820 vials |
| Recall Reason | Failed Impurities/Degradation Specifications |
| Drug Classification | Class III |
| Drug Code Info | 20230913 |
| Product NDC | 72485-503 72485-501 72485-502 |
| Drug UPC | 0372485503018 0372485501014 0372485502011 |
| Recall Initiation Date | 20230814 |
| Report Date | 20230913 |
| Classification Date | 20230906 |
| Address | 895 & 897 Survey No Gummidipoondi, India |
| Recalling Firm | Caplin Steriles Limited |
| Initial Notification | |
| Unique Ingredient Identifier | 9K8XR81MO8 |
| Drug Application Number | ANDA214380 |
| Structured Product Labeling (SPL ID) | fde1e354-4f15-4ade-9ae3-db2ba67e0431 |
| Structured Product Labeling (SPL Set ID) | fde1e354-4f15-4ade-9ae3-db2ba67e0431 |
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