🔍 RecallPedia

Irbesartan 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

Class I - Dangerous
💊 Drugs Recalled: October 12, 2021 Lupin Pharmaceuticals Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    a) 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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Lupin Pharmaceuticals Inc.
Reason for Recall:
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Irbesartan 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

Product Codes/Lot Numbers:

a) 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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0090-2022

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