Recalls / Class III
Class IIID-0880-2022
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
- Affected lot / code info
- Lot # 1003829, Exp date 1/31/23
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.
Recalling firm
- Firm
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 1603 cartons
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2022-05-03
- FDA classified
- 2022-05-18
- Posted by FDA
- 2022-05-25
- Terminated
- 2023-09-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0880-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.