Recalls / Class II
Class IID-1082-2015
Product
NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; 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 457529, exp. 08/2016
Why it was recalled
Failed Dissolution Specification; 6 month time point
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
- 13,392 bottles (100 count)
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2015-04-21
- FDA classified
- 2015-05-14
- Posted by FDA
- 2015-05-20
- Terminated
- 2015-12-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1082-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.