Product Safety Recalls

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RIFAMPIN Recall D-1547-2022

Description: Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30

RIFAMPIN Recall D-1547-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1547-2022
Event ID90880
BrandRIFAMPIN
Generic NameRIFAMPIN
ManufacturerRIFAMPIN
Original Package?1
Active SubstanceRIFAMPIN
Drug RouteORAL
DistributionUSA Nationwide and Puerto Rico
Quantity18,145 bottles
Recall ReasonFailed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Drug ClassificationClass II
Drug Code Info20221005
Product NDC61748-015 61748-018
Product NUIN0000175500 M0019113
Pharma Class (EPC)Rifamycin Antibacterial [EPC]
Pharma Class (CS)Rifamycins [CS]
Recall Initiation Date20220921
Report Date20221005
Classification Date20220928
Address5605 Centerpoint Ct Ste A
Gurnee, IL 60031-5278
United States
Recalling FirmAkorn, Inc.
Initial Notification Letter
Unique Ingredient IdentifierVJT6J7R4TR
Drug Application NumberANDA065028
Structured Product Labeling (SPL ID)eb950d35-ef45-4f4b-a183-982d7c4d48a7
Structured Product Labeling (SPL Set ID)26a2dbca-5090-4f6c-99ed-e11a70bb5af0
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