Class II · Moderate risk
Nitrofurantoin Capsules
Failed Dissolution Specifications
Nitrofurantoin Capsules
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
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.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
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
Affected NDCs
68084-0446-01
68084-0446-11
Compare with the code on your package — it is the most precise check available.
Drug: Nitrofurantoin
- Recalling firm
- American Health Packaging
- NDC code
- 68084-446-11
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0880-2022 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Nitrofurantoin recalls
See all
Class II · Moderate risk
Nitrofurantoin Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Nitrofurantoin Capsules USP
Failed Dissolution Specifications
Class II · Moderate risk
Nitrofurantoin Monohydrate/Macrycrystals Capsules
Failed dissolution specifications
Other recalls by American Health Packaging
All 2022 recalls
Class III · Low risk
Buprenorphine Sublingual Tablets
Labeling: Label Mix-up
Class III · Low risk
Cyanocobalamin Injection
Subpotent Drug: Out of specification for assay.
Class II · Moderate risk
Oxycodone Hydrochloride Oral Solution
Impurity failure at 0-time of the repackaged lot.
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
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