Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles manufactured at Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    VASERETIC 10-25MG TAB 100CT Lot # 12J022P exp. 9/30/2014 VASERETIC 10-25MG TAB 100CT Lot # 13G047P exp. 07/31/2015
  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:
Valeant Pharmaceuticals North America LLC
Reason for Recall:
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles manufactured at Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada

Product Codes/Lot Numbers:

VASERETIC 10-25MG TAB 100CT Lot # 12J022P exp. 9/30/2014 VASERETIC 10-25MG TAB 100CT Lot # 13G047P exp. 07/31/2015

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0018-2015

Related Recalls

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

Jan 30, 2019 Prescription Drugs Nationwide View Details →

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

Jan 30, 2019 Prescription Drugs Nationwide View Details →

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

Jan 30, 2019 Prescription Drugs Nationwide View Details →