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Class II · ModerateActive recall

Valsartan And Hydrochlorothiazide

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

Does this affect you?
Check your lot numberLot # HRSA17033-A, exp. date 10/2020 Lot # HRSA17034-A, exp. date 10/2020 Lot # HRSA17035-A, exp. date 10/2020 Lot # HRSA17036-A, exp. date 10/2020 Lot # HRSA17037-A, exp. date 10/2020
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 nameVALSARTAN AND HYDROCHLOROTHIAZIDE
Generic nameVALSARTAN AND HYDROCHLOROTHIAZIDE
Active ingredient(s)HYDROCHLOROTHIAZIDE, VALSARTAN
Distributed by / forAurobindo Pharma USA, Inc., Dayton, NJ 08810
NDC65862-550-90
Show the full FDA record
Full product labelValsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-550-90.
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.
Quantity23,016 bottles
Recall initiated2018-12-31
Report date2019-01-23
Recall completed—
Recall numberD-0365-2019
ClassificationClass II
FDA statusOngoing
Origin on fileEast Windsor NJ United States

Related

Valsartan recallsHydrochlorothiazide 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.