Recall: D-0452-2017

Class II - Potentially Harmful

Class IIClassification

2016-12-28Initiated

TerminatedStatus

Dr. Reddy's Laboratories, Inc.Firm

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

Failed Dissolution Specifications; 18 month stability time point

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.