Why it was recalled
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
Product 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.
Lot numbers, UPCs & expiration codes
Lot # a) H79652, Exp. 10/15; b) H79653, Exp. 10/15
Where it was sold
Pfizer shipped the affected product to 4,447 direct accounts. No federal government accounts received the affected product directly from Pfizer Inc.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0292-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 3, 2014
- FDA report date
- Dec 17, 2014
- Quantity
- 31,569 HDPE Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0292-2015, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 69724
- Address
- 235 East 42nd Street
- Code information
- Lot # a) H79652, Exp. 10/15; b) H79653, Exp. 10/15
- Postal code
- 10017-5703
- Report date
- Dec 17, 2014
- Product type
- Drugs
- Recall number
- D-0292-2015
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 31,569 HDPE Bottles
- Termination date
- Sep 27, 2016
- Reason for recall
- Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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.
- Distribution pattern
- Pfizer shipped the affected product to 4,447 direct accounts. No federal government accounts received the affected product directly from Pfizer Inc.
- Recall initiation date
- Dec 3, 2014
- Initial firm notification
- Letter
- Center classification date
- Dec 9, 2014