RecallDepth
Class II Terminated

Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manufactured by West-Ward, Eatontown, NJ 07724.

Company
Hikma Pharmaceuticals Usa Inc.
Recall Initiated
May 11, 2023
Posted
May 24, 2023
Recall Number
D-0574-2023
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
1,352,475 vials
Firm Location
Cherry Hill, NJ, United States

Reason for Recall

Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.

Distribution

Nationwide in the USA and Puerto Rico

Lot / Code Info

Lots: 070086, 070128, Exp. 07/2023

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