Drug product
Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 USA, NDC 47781-303-01
D-1722-2019
Product summary
- Firm
- Alvogen, Inc
- Event
- Event 83434
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2784 bottles
- Official record key
drug-enforcement:D-1722-2019
Official wording
Reason: Failed dissolution specifications
Code information: Lot # 471976, Exp 03/2020
Distribution pattern: Natonwide, PR
Derived failure modes
-
Potency or specification failure
Failed dissolution specifications