Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61), b) 60-count bottle (NDC 0069-5800-60), Rx Only, Manufactured by Pfizer Labs, Division of Pfizer, Inc., NY, NY 10017.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # a) H79652, Exp. 10/15; b) H79653, Exp. 10/15
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Pfizer Inc.
- Reason for Recall:
- Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61), b) 60-count bottle (NDC 0069-5800-60), Rx Only, Manufactured by Pfizer Labs, Division of Pfizer, Inc., NY, NY 10017.
Product Codes/Lot Numbers:
Lot # a) H79652, Exp. 10/15; b) H79653, Exp. 10/15
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0292-2015
Related Recalls
Class I - Dangerous
Lack of Assurance of Sterility.
Class I - Dangerous
Lack of Assurance of Sterility.
Class I - Dangerous
Subpotent drug