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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 Numbers: 3066064, 3069645, 3069646, 3073142, 3073143, 3073144, 3077617
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 nameAMLODIPINE AND VALSARTAN
Generic nameAMLODIPINE AND VALSARTAN
Active ingredient(s)AMLODIPINE BESYLATE, VALSARTAN
Distributed by / forMylan Pharmaceuticals, Inc
NDC0378-1724-93
Show the full FDA record
Full product labelAmlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., NDC 0378-1724-93.
Recalling firmMylan Laboratories Limited, (Nashik FDF)
DistributionProduct was distributed throughout the United States to several major distributors, including Puerto Rico.
Quantity84,066 HDPE bottles
Recall initiated2018-12-04
Report date2018-12-19
Recall completed—
Recall numberD-0323-2019
ClassificationClass II
FDA statusOngoing
Origin on fileSinnar, Nashik District N/A India

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.