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Class II · ModerateActive recall

Amlodipine and Valsartan Tablets

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

Does this affect you?
Check your lot numberBatch: BV77D013, BV77C011, BV77D001, BV77D002, BV77D003, BV77D004, BV77D005, BV77D006, BV77D007, BV77D008, BV77D009 , BV77D010, BV77D011, BV77D012, BV77C009, BV77C010
Where it was soldNationwide USA
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: Carcinogen impurity detected in API used to manufacture drug 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 byTorrent Pharmaceuticals LTD., Indrad-382 721, India foreign manufacturer
Distributed by / forTorrent Pharma Inc.
NDC13668-204-30
Show the full FDA record
Full product labelAmlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-204-30
Recalling firmTorrent Pharma Inc.
DistributionNationwide USA
Quantity89616 bottles
Recall initiated2018-08-17
Report date2018-09-05
Recall completed—
Recall numberD-1137-2018
ClassificationClass II
FDA statusOngoing
Origin on fileBasking Ridge NJ United States

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.