FDAClass IIFebruary 8, 2017

Flucanozole Tablets recall: Failed Dissolution

Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles, Rx Only, Mfd. by: Dr. Reddy's…

Why was Flucanozole Tablets recalled?

Failed Dissolution Specifications; 18 month stability time point

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

a) 30 count C500224, exp 12/2016, C500846, exp 01/2017 b) 100 count C500224, exp 12/2016, exp 12/2016, C501608, exp 02/2017 and C503655, exp 04/2017

Product
Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles, Rx Only, Mfd. by: Dr. Reddy's…
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
a) 42,984 and b) 7,764 bottles
Distribution
Nationwide
Recall date
February 8, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls