Product Safety Recalls

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RIFAMPIN Recall D-1343-2022

Description: Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: 68180-658-06

RIFAMPIN Recall D-1343-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-1343-2022
Event ID90616
Generic NameRIFAMPIN
Original Package?1
Active SubstanceRIFAMPIN
Drug RouteORAL
DistributionProduct was distributed nationwide.
Quantity7,872/30 count bottles
Recall ReasonCGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
Drug ClassificationClass II
Drug Code Info20220824
Product NDC68180-658 68180-659
Product NUIN0000175500 M0019113
Drug UPC0368180658061
Pharma Class (EPC)Rifamycin Antibacterial [EPC]
Pharma Class (CS)Rifamycins [CS]
Recall Initiation Date20220728
Report Date20220824
Classification Date20220816
AddressHarborplace Tower111 S Calvert St Fl 21st
Baltimore, MD 21202-6174
United States
Recalling FirmLupin Pharmaceuticals Inc.
Initial Notification Letter
Unique Ingredient IdentifierVJT6J7R4TR
Drug Application NumberANDA090034
Structured Product Labeling (SPL ID)d1ecd7ff-3a5a-46c6-9ca4-71156aa8fbb1
Structured Product Labeling (SPL Set ID)b56004f0-f23d-47f6-80c7-39884fccbccc
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