Could cause temporary or reversible harm; serious harm is unlikely.
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
| Brand name | ATIVAN |
| Generic name | LORAZEPAM |
| Active ingredient(s) | LORAZEPAM |
| Distributed by / for | Hikma Pharmaceuticals USA Inc. |
| NDC | 0641-6001-25 |
| Full product label | Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6001-25, Vial NDC# 0641-6001-01 |
| Recalling firm | Hikma Pharmaceuticals USA Inc. |
| Distribution | Nationwide in the USA |
| Quantity | 301,400 vials |
| Recall initiated | 2022-07-11 |
| Report date | 2022-08-17 |
| Recall completed | 2023-09-14 |
| Recall number | D-1308-2022 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Cherry Hill NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗