FDA recall D-0452-2017

Dr. Reddy's Laboratories, Inc. · Class II · drug

Product

Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India

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-0452-2017