FDA recall D-1722-2019
Alvogen, Inc · Class II · 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
Reason for recall
Failed dissolution specifications
Distribution
Natonwide, PR
Key facts
- Status
- Terminated
- Initiation date
- 2019-07-24
- Report date
- 2019-08-21
- Termination date
- 2021-08-04
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Pine Brook, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1722-2019