🔍 RecallPedia

Irbesartan Bulk Active Pharmaceutical Ingredient.

Class I - Dangerous
💊 Drugs Recalled: October 24, 2018 Aurobindo Pharma Limited (Unit I) Other Drugs

What Should You Do?

  1. Check if you have this product:
    Manufacturing batch numbers: 1601100782, dispatch batch number 1601101589, exp. date 12/01/2018 1601100783, dispatch batch number 1601101590, exp. date 12/01/2018 1701111861, dispatch batch number 1701113404, exp. date 09/01/2020 1701112170, dispatch batch number 1701113405, exp. date 09/01/2020 1701112501, dispatch batch number 1701113406, exp. date 09/01/2020 1701112056, dispatch batch number 1701113407, exp. date 09/01/2020 1701112558, dispatch batch number 1701114283, exp. date 10/01/2020 1701112559, dispatch batch number 1701114285, exp. date 10/01/2020 1701112589, dispatch batch number 1701114286, exp. date 10/01/2020 1701113300, dispatch batch number 1701114289, exp. date 10/01/2020 1701113301, dispatch batch number 1701114291, exp. date 10/01/2020 1701113302, dispatch batch number 1701114708, exp. date 10/01/2020 1701113312, dispatch batch number 1701114709, exp. date 10/01/2020 1701115460, dispatch batch number 1701117039, exp. date 11/01/2020 1701115974, dispatch batch number 1701117040, exp. date 11/01/2020 1701115460, dispatch batch number 1701117041, exp. date 11/01/2020 1701115738, dispatch batch number 1701117042, exp. date 11/01/2020 1701115739, dispatch batch number 1701117043, exp. date 11/01/2020 1701115740, dispatch batch number 1701117044, exp. date 11/01/2020 1701115741, dispatch batch number 1701117045, exp. date 11/01/2020 1701115742, dispatch batch number 1701117046, exp. date 11/01/2020
  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:
Aurobindo Pharma Limited (Unit I)
Reason for Recall:
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Irbesartan Bulk Active Pharmaceutical Ingredient.

Product Codes/Lot Numbers:

Manufacturing batch numbers: 1601100782, dispatch batch number 1601101589, exp. date 12/01/2018 1601100783, dispatch batch number 1601101590, exp. date 12/01/2018 1701111861, dispatch batch number 1701113404, exp. date 09/01/2020 1701112170, dispatch batch number 1701113405, exp. date 09/01/2020 1701112501, dispatch batch number 1701113406, exp. date 09/01/2020 1701112056, dispatch batch number 1701113407, exp. date 09/01/2020 1701112558, dispatch batch number 1701114283, exp. date 10/01/2020 1701112559, dispatch batch number 1701114285, exp. date 10/01/2020 1701112589, dispatch batch number 1701114286, exp. date 10/01/2020 1701113300, dispatch batch number 1701114289, exp. date 10/01/2020 1701113301, dispatch batch number 1701114291, exp. date 10/01/2020 1701113302, dispatch batch number 1701114708, exp. date 10/01/2020 1701113312, dispatch batch number 1701114709, exp. date 10/01/2020 1701115460, dispatch batch number 1701117039, exp. date 11/01/2020 1701115974, dispatch batch number 1701117040, exp. date 11/01/2020 1701115460, dispatch batch number 1701117041, exp. date 11/01/2020 1701115738, dispatch batch number 1701117042, exp. date 11/01/2020 1701115739, dispatch batch number 1701117043, exp. date 11/01/2020 1701115740, dispatch batch number 1701117044, exp. date 11/01/2020 1701115741, dispatch batch number 1701117045, exp. date 11/01/2020 1701115742, dispatch batch number 1701117046, exp. date 11/01/2020

Distribution:

Distributed in: NY

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0127-2019