FDAHealthJuly 22, 2025
Hikma Pharmaceuticals USA Inc. — Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
⚠️ Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 22, 2025
Distributed Nationwide in the USA
What's affected?
- 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
- Brand
- LORAZEPAM
- Lot code
- K24118
Additional details
Lot # K24118, exp. date 10/31/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 382,775 1mL vials.
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