Drug product
Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 USA Dist. by: Almatica Pharma, Inc. Pine Brook, NJ 07058 USA, NDC 52427-285-01
D-1723-2019
Product summary
- Firm
- Alvogen, Inc
- Event
- Event 83434
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4272 bottles
- Official record key
drug-enforcement:D-1723-2019
Official wording
Reason: Failed dissolution specifications
Code information: Lot # 472990, Exp 03/2020
Distribution pattern: Natonwide, PR
Derived failure modes
-
Potency or specification failure
Failed dissolution specifications