FDA recall D-0451-2017
Dr. Reddy's Laboratories, Inc. · Class II · drug
Product
Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India --- NDC 55111-145-12
Reason for recall
Failed Dissolution Specifications; 18 month stability time point
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2016-12-28
- Report date
- 2017-02-08
- Termination date
- 2017-10-19
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Princeton, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0451-2017