Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-0...
FDA Recall #D-0449-2017 — Class II — December 28, 2016
Product Description
Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
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
a) 2472 bottles, b) 780 bottles
Distribution
Nationwide
Code Information
a) 30 count C500221, exp 12/2016, C502342, exp 03/2017 b) 100 count C500221, exp 12/2016, C502342, exp 03/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated