FDA recall D-0551-2025

Hikma Pharmaceuticals USA Inc. · Class II · 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

Reason for recall

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

Distribution

Distributed Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2025-07-22
Report date
2025-08-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cherry Hill, NJ, United States

Primary source

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