Product Safety Recalls

Product Recall Tracker

RIFAMPIN Recall D-0774-2022

Description: Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., NDC 67457-445-60

RIFAMPIN Recall D-0774-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0774-2022
Event ID89910
BrandRIFAMPIN
Generic NameRIFAMPIN
ManufacturerRIFAMPIN
Original Package?1
Active SubstanceRIFAMPIN
Drug RouteINTRAVENOUS
DistributionNationwide in the USA
Quantity33,893 vials
Recall ReasonFailed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
Drug ClassificationClass II
Drug Code Info20220427
Product NDC67457-445
Product NUIN0000175500 M0019113
Pharma Class (EPC)Rifamycin Antibacterial [EPC]
Pharma Class (CS)Rifamycins [CS]
Recall Initiation Date20220407
Report Date20220427
Classification Date20220415
Address3711 Collins Ferry Rd
Morgantown, WV 26505-2362
United States
Recalling FirmMylan Pharmaceuticals Inc
Initial Notification Letter
Unique Ingredient IdentifierVJT6J7R4TR
Drug Application NumberANDA065421
Structured Product Labeling (SPL ID)de4817e4-c300-4990-9c2b-d816917c8bb4
Structured Product Labeling (SPL Set ID)8be91604-d7cd-4f2b-997d-e3364e4092e5
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