Drug Enforcement D-0551-2025

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

Status

Ongoing

Classification

Class II

Report Date

August 6, 2025

Termination Date

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Product Information

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
Product quantity
382,775 1mL vials
Reason for recall
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Distributed Nationwide in the USA

Location & Firm

Recalling firm
Hikma Pharmaceuticals USA Inc.
Address
2 Esterbrook Ln

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0551-2025
Event ID
97294
Recall initiation date
July 22, 2025
Center classification date
July 31, 2025
Code info
Lot # K24118, exp. date 10/31/2026
More code info
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