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Class II · ModerateActive recall

Valsartan

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

Does this affect you?
Check your lot numberLot Numbers: 3063783 3063784 3063785 3064092 3064093 3064094 3070349 3070350 3070351 3070352 3070353 3070354 3079030 3079031 3079032 3079033 3080011 3080224 3081498 3081500 3087126 3088476
Where it was soldProduct was distributed throughout the United States to several major distributors, including Puerto Rico.
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

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found 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
Generic nameVALSARTAN
Active ingredient(s)VALSARTAN
Distributed by / forMylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A
NDC0378-5815-77
Show the full FDA record
Full product labelValsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5815-77.
Recalling firmMylan Laboratories Limited, (Nashik FDF)
DistributionProduct was distributed throughout the United States to several major distributors, including Puerto Rico.
Quantity129,754 HDPE bottles
Recall initiated2018-12-04
Report date2018-12-19
Recall completed—
Recall numberD-0327-2019
ClassificationClass II
FDA statusOngoing
Origin on fileSinnar, Nashik District N/A India

Related

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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.