Product Safety Recalls

Product Recall Tracker

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

Mandated?Voluntary: Firm initiated
Recall NumberD-0880-2022
Event ID90191
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
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied. is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.