Drug product
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
D-0551-2025
Product summary
- Event
- Event 97294
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 382,775 1mL vials
- Official record key
drug-enforcement:D-0551-2025
Official wording
Reason: Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Code information: Lot # K24118, exp. date 10/31/2026
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Potency or specification failure
out-of-Specification