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Class II · ModerateRecall completed

Irbesartan

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

Does this affect you?
Check your lot numbera) Lot# H804310, exp. date 31/08/2021 H900050, exp. date 30/11/2021 H902262, exp. date 31/05/2022 b) Lot# H000845, exp. date 28/02/2023 H000846, exp. date 28/02/2023 H000965, exp. date 31/03/2023 H805345, exp. date 30/11/2021 H805346, exp. date 30/11/2021 H805347, exp. date 30/11/2021 H805724, exp. date 30/11/2021 H900061, exp. date 31/12/2021 H900062, exp. date 31/12/2021 H900445, exp. date 31/01/2022 H901489, exp. date 31/03/2022 H901490, exp. date 31/03/2022 H901491, exp. date 31/03/2022 H902261, exp. date 31/05/2022
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

Made byLupin Pharmaceuticals, Inc.
Brand nameIRBESARTAN
Generic nameIRBESARTAN
Active ingredient(s)IRBESARTAN
Distributed by / forLupin Pharmaceuticals Inc.
NDC68180-412-06
Show the full FDA record
Full product labelIrbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only
Recalling firmLupin Pharmaceuticals Inc.
DistributionProduct was distributed to major distributors who may have further distributed the product nationwide.
Quantity119,544 bottles
Recall initiated2021-10-12
Report date2021-11-10
Recall completed2023-01-30
Recall numberD-0088-2022
ClassificationClass II
FDA statusTerminated
Origin on fileBaltimore MD United States

Related

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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.