Nitrofurantoin Capsules 100 mg recalled for failed dissolution specifications
American Health Packaging is recalling Nitrofurantoin Capsules 100 mg due to dissolution failure. The drug release results were above specification. No illnesses have been reported.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recalls are typically scored 1 or 2. With no reported illnesses and a manufacturing quality defect rather than a safety hazard with confirmed harm, this scores as Moderate.
Plain-English summary
American Health Packaging is recalling Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg in unit-dose blister packs, distributed nationwide. The recall affects 1,603 cartons of Lot #1003829 with an expiration date of January 31, 2023, with NDC 68084-446-01.
The recall is due to dissolution failure of the repackaged lot. Quality testing showed that drug release results were above specification, meaning the medication may not release properly when taken.
Patients or healthcare providers who have this medication should verify the lot number. If you have Lot #1003829, contact your healthcare provider or pharmacy. Pharmacies and healthcare providers should remove the affected lot from inventory and contact the manufacturer for return instructions.
The recalled product
- Product
- 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
- Manufacturer
- American Health Packaging
- Category
- Drug
- Hazard
- Affected units
- 1,603
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 1003829
- Exp date 1/31/23
Distribution
Distributed nationwide across the United States.
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