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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0880-2022 |
| Event ID | 90191 |
| Brand | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) |
| Generic Name | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) |
| Manufacturer | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) |
| Active Substance | NITROFURANTOIN NITROFURANTOIN MONOHYDRATE |
| Drug Route | ORAL |
| Distribution | Nationwide USA |
| Quantity | 1603 cartons |
| Recall Reason | Failed 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 Classification | Class III |
| Drug Code Info | 20220525 |
| Product NDC | 68084-446 |
| Product NUI | N0000175494 M0014892 |
| Pharma Class (EPC) | Nitrofuran Antibacterial [EPC] |
| Pharma Class (CS) | Nitrofurans [CS] |
| Recall Initiation Date | 20220503 |
| Report Date | 20220525 |
| Classification Date | 20220518 |
| Address | 2550 John Glenn Ave Ste A Columbus, OH 43217-1188 United States |
| Recalling Firm | American Health Packaging |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 927AH8112L E1QI2CQQ1I |
| Drug Application Number | ANDA077066 |
| 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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