FDAClass IIMarch 9, 2016

Capecitabine tablets USP 500 mg recall: Failed Dissolution

Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries sro, Czech…

Why was Capecitabine tablets USP 500 mg recalled?

Failed Dissolution Specifications: low test results at the 18 month 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?

Lot # 3A404012V, Exp. 4/2016

Product
Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries sro, Czech…
Recalling firm
Teva North America
Quantity
1,895 bottles
Distribution
Nationwide
Recall date
March 9, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls