Dr. Reddy's Laboratories, Inc. recalls Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles, Rx Only, M
Recalled February 8, 2017 · FDA recall D-0450-2017 · Dr. Reddy's Laboratories
Hazard
Failed Dissolution Specifications; 18 month stability time point · FDA Class II
Units
a) 42,984 and b) 7,764 bottles
Sold at
Nationwide
Description
Failed Dissolution Specifications; 18 month stability time point
Product
Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Manufacturer(s)
Dr. Reddy's Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →