Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-...
FDA Recall #D-0452-2017 — Class II — December 28, 2016
Product Description
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 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) 38,832 and b) 5,064 bottles
Distribution
Nationwide
Code Information
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated