Drug recall D-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
Reason for recall
Failed Dissolution Specification; 6 month time point
Lots and codes
Lot 457529, exp. 08/2016
Recall details
- Recalling firm
- Alvogen, Inc, Pine Brook, NJ
- Quantity
- 13,392 bottles (100 count)
- Distribution
- Nationwide and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 21, 2015
- Terminated
- December 4, 2015
Related products
- Nitrofurantoin Monohydrate/ Macrocrystalline – drug information
- NDC 47781-303 Nitrofurantoin Monohydrate/ Macrocrystalline · Nitrofurantoin 25 mg/1; Nitrofurantoin Monohydrate 75 mg/1 · Alvogen Inc.