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Class II · ModerateActive recall

Amlodipine

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

Does this affect you?
Check your lot numberNDC [redacted-phone] & NDC [redacted-phone] Lot # 20X006
Where it was soldUSA Nationwide 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

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in 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

Distributed by / forTEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454
NDC0093-7810-56
Show the full FDA record
Full product labelAmlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7810-56) & 90-count bottles (NDC 0093-7810-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
Recalling firmTeva Pharmaceuticals USA
DistributionUSA Nationwide including Puerto Rico.
Quantity19,458 bottles
Recall initiated2018-11-27
Report date2018-12-19
Recall completed—
Recall numberD-0308-2019
ClassificationClass II
FDA statusOngoing
Origin on fileNorth Wales PA United States

Related

Amlodipine 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.