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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 # 3084886, exp. date 2/2019 Lot # 3093804, exp. date 12/2019
Where it was soldProduct was distributed 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-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

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 byMade in India foreign manufacturer
Brand nameVALSARTAN AND HYDROCHLOROTHIAZIDE
Generic nameVALSARTAN AND HYDROCHLOROTHIAZIDE
Active ingredient(s)HYDROCHLOROTHIAZIDE, VALSARTAN
Distributed by / forMylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A
NDC0378-6325-05
Show the full FDA record
Full product labelValsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A. NDC 0378-6325-05.
Recalling firmMylan Pharmaceuticals Inc.
DistributionProduct was distributed throughout the United States.
Quantity5,660 bottles
Recall initiated2018-11-20
Report date2018-12-19
Recall completed—
Recall numberD-0317-2019
ClassificationClass II
FDA statusOngoing
Origin on fileMorgantown WV 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.