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Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorke...

FDA Recall #D-0876-2018 — Class III — May 25, 2018

Recall #D-0876-2018 Date: May 25, 2018 Classification: Class III Status: Terminated

Product Description

Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90

Reason for Recall

Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).

Recalling Firm

Jubilant Cadista Pharmaceuticals, Inc. — Salisbury, MD

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

2,328 bottles (Lot VR417065A) and 2,352 bottles (Lot VR417066A)

Distribution

IN, MI, MS, NC, NJ, NY and OH

Code Information

Lot #: VR417065A, VR417066A, Exp 10/2019

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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