Class II
Terminated
NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01
- Company
- Alvogen, Inc
- Recall Initiated
- April 21, 2015
- Posted
- May 20, 2015
- Recall Number
- D-1082-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 13,392 bottles (100 count)
- Firm Location
- Pine Brook, NJ, United States
Reason for Recall
Failed Dissolution Specification; 6 month time point
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot 457529, exp. 08/2016
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