🔍 RecallPedia

LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) 1000-count (NDC: 13668-115-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ

Class I - Dangerous
💊 Drugs Recalled: February 28, 2019 Torrent Pharma Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Count, lots, expiry: [90-count bottle] Lots 4DU3E014, 4DU3E015, exp 1/31/2021; Lot 4DU3E065, exp 7/31/2021; [1000-count bottle] Lot 4DU3D018, exp 11/30/2020; Lots 4DU3E062, 4DU3E063, exp 6/30/2021
  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:
Torrent Pharma Inc.
Reason for Recall:
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) 1000-count (NDC: 13668-115-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ

Product Codes/Lot Numbers:

Count, lots, expiry: [90-count bottle] Lots 4DU3E014, 4DU3E015, exp 1/31/2021; Lot 4DU3E065, exp 7/31/2021; [1000-count bottle] Lot 4DU3D018, exp 11/30/2020; Lots 4DU3E062, 4DU3E063, exp 6/30/2021

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1116-2019

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