LORAZEPAM Recall D-1307-2022
Description: Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6044-25, Vial NDC# 0641-6044-01
LORAZEPAM Recall D-1307-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1307-2022 |
| Event ID | 90583 |
| Brand | LORAZEPAM |
| Generic Name | LORAZEPAM |
| Manufacturer | LORAZEPAM |
| Original Package? | 1 |
| Active Substance | LORAZEPAM |
| Drug Route | INTRAMUSCULAR |
| Distribution | Nationwide in the USA |
| Quantity | 4,739,000 vials |
| Recall Reason | Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples. |
| Drug Classification | Class II |
| Drug Code Info | 20220817 |
| Product NDC | 0641-6044 0641-6046 0641-6045 |
| Product NUI | N0000175694 M0002356 |
| Pharma Class (EPC) | Benzodiazepine [EPC] |
| Pharma Class (CS) | Benzodiazepines [CS] |
| Recall Initiation Date | 20220711 |
| Report Date | 20220817 |
| Classification Date | 20220805 |
| Address | 2 Esterbrook Ln Cherry Hill, NJ 08003-4002 United States |
| Recalling Firm | Hikma Pharmaceuticals USA Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | O26FZP769L |
| Drug Application Number | NDA018140 |
| Structured Product Labeling (SPL ID) | eb0543f9-51fb-4847-be6a-68d83081486c |
| Structured Product Labeling (SPL Set ID) | e9b54e42-04cf-4c62-90e1-36f7b31a4e81 |
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