Recalls / Class II
Class IID-0232-2021
Product
Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton: 68084-446-01; NDC Blister Card: 68084- 446-11
- Affected lot / code info
- Lot # 193757, Exp 1/31/2022
Why it was recalled
Failed Dissolution Specifications
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
- 1948 cartons
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2021-01-07
- FDA classified
- 2021-01-15
- Posted by FDA
- 2021-01-27
- Terminated
- 2022-08-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0232-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.