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Class III · Lower riskRecall completed

Valsartan

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: VR417062A, Exp. 09/2019; VR417063A, VR417064A, Exp. 10/2019
Where it was soldProduct was distributed throughout the United States to wholesalers and retailers.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byJubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA foreign manufacturer
Brand nameVALSARTAN
Generic nameVALSARTAN
Active ingredient(s)VALSARTAN
Distributed by / forJubilant Cadista Pharmaceuticals, Inc.
NDC59746-363-90
Show the full FDA record
Full product labelValsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-363-90
Recalling firmJubilant Cadista Pharmaceuticals, Inc.
DistributionProduct was distributed throughout the United States to wholesalers and retailers.
Quantity7,048 bottles
Recall initiated2018-08-14
Report date2018-08-29
Recall completed2020-01-08
Recall numberD-1106-2018
ClassificationClass III
FDA statusTerminated
Origin on fileSalisbury MD United States

Related

Valsartan recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.