Recalls / Class II
Class IID-0421-2021
Product
Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only NDC 47781-306-01 Manufactured by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 Distributed by: Alvogen, Inc. Parsippany, NJ 07054 U.S.A.
- Brand name
- Nitrofurantoin Macrocrystals
- Generic name
- Nitrofurantoin Macrocrystals
- Active ingredient
- Nitrofurantoin
- Route
- Oral
- NDCs
- 47781-306, 47781-307, 47781-308
- FDA application
- NDA016620
- Affected lot / code info
- 486942
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Alvogen Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 15 bottles
- Distribution pattern
- FL, GA, SC
Timeline
- Recall initiated
- 2021-03-15
- FDA classified
- 2021-05-24
- Posted by FDA
- 2021-06-02
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0421-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.