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FDAFDA · Food and drugs·Recall number D-0452-2017

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

Published February 8, 2017 · Recall initiated: December 28, 2016

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Failed Dissolution Specifications; 18 month stability time point

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
FLUCONAZOLE
Manufacturer
Dr. Reddy's Laboratories, Inc.
Distributor
Nationwide
UPC
0355111145127
Lot
a) 30 count C500228, exp 12/2016, C500848 and C500850, exp 01/2017 C503651 and C503653, exp 04/2017, b) 100 count C500226, exp 12/2016, C500848, C500850, exp 01/2017, C503649 and C503653, exp 04/2017
Risk classification
Class II
Area (FDA)
drug
Country
United States

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