🔍 RecallPedia

Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. NDC# 0904-6595-61.

Class I - Dangerous
💊 Drugs Recalled: July 18, 2018 MAJOR PHARMACEUTICALS Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Major Label Unit Dose 10 x 10 Cartons 160 mg Item # 302087. Lot# T-01269 (Expiry: 7/18). Lot# T-01524 (Expiry: 2/19). Lot# T-01646 (Expiry: 5/19). Lot# T-01668 (Expiry: 5/19). Lot# T-01788 (Expiry: 5/19).
  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:
MAJOR PHARMACEUTICALS
Reason for Recall:
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. NDC# 0904-6595-61.

Product Codes/Lot Numbers:

Major Label Unit Dose 10 x 10 Cartons 160 mg Item # 302087. Lot# T-01269 (Expiry: 7/18). Lot# T-01524 (Expiry: 2/19). Lot# T-01646 (Expiry: 5/19). Lot# T-01668 (Expiry: 5/19). Lot# T-01788 (Expiry: 5/19).

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0967-2018

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