Recalls / Class II
Class IID-1722-2019
Product
Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 USA, NDC 47781-303-01
- Brand name
- Nitrofurantoin Monohydrate/ Macrocrystalline
- Generic name
- Nitrofurantoin Monohydrate/macrocrystalline
- Active ingredients
- Nitrofurantoin, Nitrofurantoin Monohydrate
- Route
- Oral
- NDC
- 47781-303
- FDA application
- NDA020064
- Affected lot / code info
- Lot # 471976, Exp 03/2020
Why it was recalled
Failed dissolution specifications
Recalling firm
- Firm
- Alvogen, Inc
- Manufacturer
- Alvogen Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10 Bloomfield Ave Bldg B Ste 2, N/A, Pine Brook, New Jersey 07058-9743
Distribution
- Quantity
- 2784 bottles
- Distribution pattern
- Natonwide, PR
Timeline
- Recall initiated
- 2019-07-24
- FDA classified
- 2019-08-12
- Posted by FDA
- 2019-08-21
- Terminated
- 2021-08-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1722-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.