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Class II · ModerateRecall completed

Valsartan Tablets USP 160 mg

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

Does this affect you?
Check your lot numberLot 179791, Mar 2020
Where it was soldNationwide USA and 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

CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.

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

Distributed by / forAmerican Health Packaging, Columbus, Ohio 43217 (Individual Dose
NDC60687-139-11
Show the full FDA record
Full product labelValsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 (Individual Dose NDC:60687-139-11, Carton NDC#: 60687-139-01)
Recalling firmAmerican Health Packaging
DistributionNationwide USA and Puerto Rico
Quantity3337 cartons
Recall initiated2019-03-06
Report date2019-03-27
Recall completed2020-09-09
Recall numberD-1047-2019
ClassificationClass II
FDA statusTerminated
Origin on fileColumbus OH United States

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.