FDA Drug recall D-0574-2023
Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manufac…
- FDA Drug
- Class II
- terminated
- Published 2023-05-24
On 2023-05-24 the FDA classified a Class II recall of Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manufac… by Hikma Pharmaceuticals Usa, citing failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0574-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-05-11 |
| Published | 2023-05-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Hikma Pharmaceuticals Usa |
| Distribution | US |
Product
Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manufactured by West-Ward, Eatontown, NJ 07724.
Reason
Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
Identifiers
| ndc | 0641-6044-01 |
|---|---|
| ndc | 0641-6044-25 |
| ndc | 0641-6046-01 |
| ndc | 0641-6046-10 |
| ndc | 0641-6045-01 |
| ndc | 0641-6045-25 |
| ndc | 0641-6047-01 |
| ndc | 0641-6047-10 |
| code_info | Lots: 070086, 070128, Exp. 07/2023 |
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-0574-2023%22
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