FDA Drug recall D-1310-2022
Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922
- FDA Drug
- Class II
- terminated
- Published 2022-08-17
On 2022-08-17 the FDA classified a Class II recall of Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922 by Hikma Pharmaceuticals Usa, citing failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1310-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-07-11 |
| Published | 2022-08-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Hikma Pharmaceuticals Usa |
| Distribution | US |
Product
Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# NDC# 0641-6045-25, Vial NDC# 0641-6045-01
Reason
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
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 | Lot # 070096, exp. date 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-1310-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.