LORAZEPAM Recall D-1309-2022
Description: Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# 0641-6048-25, Vial NDC# 0641-6048-01
LORAZEPAM Recall D-1309-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1309-2022 |
| 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 | 713,550 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 | 0641-6048 0641-6050 0641-6049 |
| 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) | 1565c902-77fe-4187-9bb9-844143480510 |
| Structured Product Labeling (SPL Set ID) | 4084fa74-9fd2-45ef-9d56-27bfa31d4e46 |
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