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Class II · ModerateRecall completed

Valsartan

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

Does this affect you?
Check your lot numberAll Lots with expiration dates 7/2018 to 6/2020
Where it was soldNationwide
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 byCamber Pharmaceuticals, Inc.
Brand nameVALSARTAN
Generic nameVALSARTAN
Active ingredient(s)VALSARTAN
Distributed by / forCamber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Pollepally Jadcherla Mahabubnagar - 509-301, India
NDC31722-747-90
Show the full FDA record
Full product labelCamber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Pollepally Jadcherla Mahabubnagar - 509-301, India. NDC 31722-747-90 UPC 331722747905
Recalling firmHetero Labs Limited Unit V
DistributionNationwide
Quantity441,408 bottles
Recall initiated2018-08-08
Report date2018-08-29
Recall completed—
Recall numberD-1115-2018
ClassificationClass II
FDA statusCompleted
Origin on fileJadcherla Mandal, Mahaboob Nagar India

Related

Valsartan 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.