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Class II · ModerateRecall completed

Irbesartan and Hydrochlorothiazide Tablets USP

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

Does this affect you?
Check your lot numbera) Lot# H804192, exp. date 31/08/2021 H805348, exp. date 30/11/2021 H900065, exp. date 31/12/2021 H902264; exp. date 31/05/2022 b) Lot# H804082, exp. date 31/08/2021 H804121, exp. date 31/08/2021 H804338, exp. date 31/08/2021 H804538, exp. date 30/09/2021 H804539, exp. date 30/09/2021 H805349, exp. date 30/11/2021 H805350, exp. date 30/11/2021 H900066, exp. date 31/12/2021 H900067, exp. date 31/12/2021 H902265, exp. date31/05/2022 H902275, exp. date31/05/2022 H902276, exp. date31/05/2022 H902531, exp. date 30/04/2022 H902532, exp. date 30/04/2022
Where it was soldProduct was distributed to major distributors who may have further distributed the product nationwide.
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: impurity N-nitrosoirbesartan detected in API

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 / forLupin Pharmaceuticals Inc.
NDC68180-414-06
Show the full FDA record
Full product labelIrbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx only
Recalling firmLupin Pharmaceuticals Inc.
DistributionProduct was distributed to major distributors who may have further distributed the product nationwide.
Quantity98,052 bottles
Recall initiated2021-10-12
Report date2021-11-10
Recall completed2023-01-30
Recall numberD-0090-2022
ClassificationClass II
FDA statusTerminated
Origin on fileBaltimore MD United States

Related

Hydrochlorothiazide recallsIrbesartan 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.