FDA Drug recall D-1309-2022
Lorazepam Injection, USP, 2mg/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, 2mg/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-1309-2022 |
| 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, 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
Reason
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Identifiers
| ndc | 0641-6048-01 |
|---|---|
| ndc | 0641-6048-25 |
| ndc | 0641-6050-01 |
| ndc | 0641-6050-10 |
| ndc | 0641-6049-01 |
| ndc | 0641-6049-25 |
| ndc | 0641-6051-01 |
| ndc | 0641-6051-10 |
| code_info | Lot # 070088, 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.
Other recalls by Hikma Pharmaceuticals Usa
- Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manuf…
FDA Drug · Class II · 2026-09-02 · Hikma Pharmaceuticals Usa - Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Be…
FDA Drug · Class II · 2026-05-06 · Hikma Pharmaceuticals Usa - Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
FDA Drug · Class II · 2025-08-06 · Hikma Pharmaceuticals Usa - Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma…
FDA Drug · Class I · 2024-08-28 · Hikma Pharmaceuticals Usa - Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, ND…
FDA Drug · Class II · 2024-03-27 · Hikma Pharmaceuticals Usa
All Hikma Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1309-2022%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.