Product Safety Recalls

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CYANOCOBALAMIN Recall D-0766-2022

Description: Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for Auromedics Pharma LLC, NDC 55150-364-01.

CYANOCOBALAMIN Recall D-0766-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0766-2022
Event ID89941
BrandCYANOCOBALAMIN
Generic NameCYANOCOBALAMIN
ManufacturerCYANOCOBALAMIN
Original Package?1
Active SubstanceCYANOCOBALAMIN
Drug RouteINTRAMUSCULAR
DistributionNationwide in the USA.
Quantity433,809 vials
Recall ReasonSubpotent Drug: Out of Specification results for Assay
Drug ClassificationClass III
Drug Code Info20220420
Product NDC55150-364
Product NUIM0022794 N0000175951
Drug UPC0355150364015
Pharma Class (EPC)Vitamin B12 [EPC]
Pharma Class (CS)Vitamin B 12 [CS]
Recall Initiation Date20220405
Report Date20220420
Classification Date20220412
Address279 Princeton Hightstown Rd
East Windsor, NJ 08520-1401
United States
Recalling FirmAurobindo Pharma USA Inc.
Unique Ingredient IdentifierP6YC3EG204
Drug Application NumberANDA213874
Structured Product Labeling (SPL ID)96dcbbb3-27d4-4ab9-aa0a-2fd2ebba6a8c
Structured Product Labeling (SPL Set ID)db84d0ea-5c15-47f5-bbe2-8d455e75695e
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