Drug product
NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01
D-1082-2015
Product summary
- Firm
- Alvogen, Inc
- Event
- Event 71003
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,392 bottles (100 count)
- Official record key
drug-enforcement:D-1082-2015
Official wording
Reason: Failed Dissolution Specification; 6 month time point
Code information: Lot 457529, exp. 08/2016
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specification