Product Safety Recalls

Product Recall Tracker

LORAZEPAM Recall D-1309-2022

Description: Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# 0641-6048-25, Vial NDC# 0641-6048-01

LORAZEPAM Recall D-1309-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-1309-2022
Event ID90583
Original Package?1
Active SubstanceLORAZEPAM
DistributionNationwide in the USA
Quantity713,550 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 NDC0641-6048 0641-6050 0641-6049
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)1565c902-77fe-4187-9bb9-844143480510
Structured Product Labeling (SPL Set ID)4084fa74-9fd2-45ef-9d56-27bfa31d4e46
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