🔍 RecallPedia

Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7 Tablets bottle, Rx only, Mfd by: Novartis Pharma Stein AG, Stein, Switzerland, NDC 0078-9420-07

Class I - Dangerous
💊 Drugs Recalled: May 17, 2013 Warner Chilcott US Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot F1002 - Exp.12/13
  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:
Warner Chilcott US LLC
Reason for Recall:
Failed Impurities/Degradation Specifications: unspecified degradation product
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7 Tablets bottle, Rx only, Mfd by: Novartis Pharma Stein AG, Stein, Switzerland, NDC 0078-9420-07

Product Codes/Lot Numbers:

Lot F1002 - Exp.12/13

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-822-2013