Product Safety Recalls

Product Recall Tracker

LORAZEPAM Recall D-1308-2022

Description: Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6001-25, Vial NDC# 0641-6001-01

LORAZEPAM Recall D-1308-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-1308-2022
Event ID90583
Original Package?1
Active SubstanceLORAZEPAM
DistributionNationwide in the USA
Quantity301,400 vials
Recall ReasonFailed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Drug ClassificationClass II
Drug Code Info20220817
Product NDC0641-6000 0641-6001 0641-6003
Product NUIN0000175694 M0002356
Pharma Class (EPC)Benzodiazepine [EPC]
Pharma Class (CS)Benzodiazepines [CS]
Recall Initiation Date20220711
Report Date20220817
Classification Date20220805
Address2 Esterbrook Ln
Cherry Hill, NJ 08003-4002
United States
Recalling FirmHikma Pharmaceuticals USA Inc.
Initial Notification Letter
Unique Ingredient IdentifierO26FZP769L
Drug Application NumberNDA018140
Structured Product Labeling (SPL ID)2d4cea58-1dfe-4bc0-bd5a-415ced5420db
Structured Product Labeling (SPL Set ID)5fc0e987-61c9-40c4-b0d5-fcea07c8733e
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