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NITROFURANTOIN Recall D-0880-2022

Description: Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 68084-446-01

NITROFURANTOIN Recall D-0880-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0880-2022
Event ID90191
BrandNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Generic NameNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
ManufacturerNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Active SubstanceNITROFURANTOIN NITROFURANTOIN MONOHYDRATE
Drug RouteORAL
DistributionNationwide USA
Quantity1603 cartons
Recall ReasonFailed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Drug ClassificationClass III
Drug Code Info20220525
Product NDC68084-446
Product NUIN0000175494 M0014892
Pharma Class (EPC)Nitrofuran Antibacterial [EPC]
Pharma Class (CS)Nitrofurans [CS]
Recall Initiation Date20220503
Report Date20220525
Classification Date20220518
Address2550 John Glenn Ave Ste A
Columbus, OH 43217-1188
United States
Recalling FirmAmerican Health Packaging
Initial Notification Letter
Unique Ingredient Identifier927AH8112L E1QI2CQQ1I
Drug Application NumberANDA077066
Structured Product Labeling (SPL ID)b028ec73-b79e-2ec0-e053-2995a90a0223
Structured Product Labeling (SPL Set ID)b8434c69-527a-4e4b-b23f-25ba424d9660
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