FDA-Drug2025-08-06Class II

Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25

Hikma Pharmaceuticals USA Inc.
Hazard

Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds

Sold states
Distributed Nationwide in the USA
Affected count
382,775 1mL vials
Manufactured in
2 Esterbrook Ln, Cherry Hill, NJ, United States
Products
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0551-2025

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