Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories,...
FDA Recall #D-0451-2017 — Class II — December 28, 2016
Product Description
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 for Recall
Failed Dissolution Specifications; 18 month stability time point
Recalling Firm
Dr. Reddy's Laboratories, Inc. — Princeton, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
59,440 blister cards
Distribution
Nationwide
Code Information
C500222, C500515, and C500517, exp 12/2016, C502343, exp 03/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated