FDAFDA · Food and drugs·Recall number D-1082-2015
NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01
Published May 20, 2015 · Recall initiated: April 21, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specification; 6 month time point
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE
- Manufacturer
- Alvogen, Inc
- Distributor
- Nationwide and Puerto Rico
- UPC
- 0347781303013
- Lot
- Lot 457529, exp. 08/2016
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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