Ativan Injection — Class II drug recall D-1308-2022
Terminated recall by Hikma Pharmaceuticals USA Inc., reported 2022-08-17, distributed nationwide. Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compound
| Recall number | D-1308-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ, United States |
| Recall initiated | 2022-07-11 |
| Classified | 2022-08-05 |
| Reported by FDA | 2022-08-17 |
| Terminated | 2023-09-14 |
| Distributed | Nationwide (US) |
| Quantity | 301,400 vials |
| Reason classes | specification failure |
| NDC | 00641-6001-01, 00641-6001-25 |
| Lot numbers | 060064Z |
| Expiration dates | 2023-06 |
Product
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
Reason for recall
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1308-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.