FDAClass IIIAugust 29, 2018

Valsartan Tablets USP recall

Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista…

Why was Valsartan Tablets USP recalled?

Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

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 #: VR217013A, Exp. 08/2019

Product
Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista…
Recalling firm
Jubilant Cadista Pharmaceuticals, Inc.
Quantity
9,552 bottles
Distribution
Product was distributed throughout the United States to wholesalers and retailers.
Recall date
August 29, 2018
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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