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Class II · ModerateActive recall

Amlodipine And Valsartan

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # VESA17013-A, exp. 10/2019 Lot # VESA17014-A, exp. 10/2019 Lot # VESA18001-A, exp. 12/2019 Lot # VESA18002-A, exp. 12/2019
Where it was soldProduct was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
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

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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 byAurobindo Pharma Limited
Brand nameAMLODIPINE AND VALSARTAN
Generic nameAMLODIPINE AND VALSARTAN
Active ingredient(s)AMLODIPINE BESYLATE, VALSARTAN
Distributed by / forAurobindo Pharma USA, Inc., Dayton, NJ 08810
NDC65862-737-30
Show the full FDA record
Full product labelAmlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30
Recalling firmAurobindo Pharma USA Inc.
DistributionProduct was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
Quantity18,408 bottles
Recall initiated2018-12-31
Report date2019-01-23
Recall completed—
Recall numberD-0361-2019
ClassificationClass II
FDA statusOngoing
Origin on fileEast Windsor NJ United States

Related

Valsartan recallsAmlodipine 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.