D-1307-2022 Class II Terminated

Recalled by Hikma Pharmaceuticals USA Inc. — Cherry Hill, NJ

Recall Details

Product Type
Drugs
Report Date
August 17, 2022
Initiation Date
July 11, 2022
Termination Date
September 14, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,739,000 vials

Product Description

Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6044-25, Vial NDC# 0641-6044-01

Reason for Recall

Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

Distribution Pattern

Nationwide in the USA

Code Information

Lot # 060064, Exp. 06/2023, 070084, Exp. 07/2023, 070126, Exp. 07/2023, 080091, Exp. 08/2023, 080060, Exp. 08/2023