Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
Reported: August 6, 2025 Initiated: July 22, 2025 #D-0551-2025
Product Description
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
Reason for Recall
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Details
- Recalling Firm
- Hikma Pharmaceuticals USA Inc.
- Units Affected
- 382,775 1mL vials
- Distribution
- Distributed Nationwide in the USA
- Location
- Cherry Hill, NJ
Frequently Asked Questions
What product was recalled? ▼
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25. Recalled by Hikma Pharmaceuticals USA Inc.. Units affected: 382,775 1mL vials.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 6, 2025. Severity: Moderate. Recall number: D-0551-2025.
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