Recall: D-0451-2017

Class II - Potentially Harmful

Class IIClassification

2016-12-28Initiated

TerminatedStatus

Dr. Reddy's Laboratories, Inc.Firm

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

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.