Product Safety Recalls

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CYANOCOBALAMIN Recall D-0790-2022

Description: Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mL Vials, Rx only, Manufactured by: Eugia Pharma Specialties Limited, Hyderabad India for BluePoint Laboratories. NDC for Carton: 68001-509-60; NDC for vial: 68001-509-59

CYANOCOBALAMIN Recall D-0790-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0790-2022
Event ID90003
BrandCYANOCOBALAMIN
Generic NameCYANOCOBALAMIN
ManufacturerCYANOCOBALAMIN
Original Package?1
Active SubstanceCYANOCOBALAMIN
Drug RouteINTRAMUSCULAR
DistributionAlabama
Quantity97,975 vials
Recall ReasonSubpotent Drug: Out of specification for assay.
Drug ClassificationClass III
Drug Code Info20220504
Product NDC68001-509
Product NUIM0022794 N0000175951
Drug UPC0368001509596
Pharma Class (EPC)Vitamin B12 [EPC]
Pharma Class (CS)Vitamin B 12 [CS]
Recall Initiation Date20220412
Report Date20220504
Classification Date20220426
Address2550 John Glenn Ave Ste A
Columbus, OH 43217-1188
United States
Recalling FirmAmerican Health Packaging
Initial Notification Letter
Unique Ingredient IdentifierP6YC3EG204
Drug Application NumberANDA213874
Structured Product Labeling (SPL ID)d2918bb9-c46b-3bf8-e053-2995a90adc92
Structured Product Labeling (SPL Set ID)034615bb-9f98-4034-b3a2-b1cc22a00a46
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