FDAFDA · Food and drugs·Recall number D-0292-2015
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.
Published December 17, 2014 · Recall initiated: December 3, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TIKOSYN
- Manufacturer
- Pfizer Inc.
- Distributor
- Pfizer shipped the affected product to 4,447 direct accounts. No federal government accounts received the affected product directly from Pfizer Inc.
- UPC
- 0300695810602
- Lot
- Lot # a) H79652, Exp. 10/15; b) H79653, Exp. 10/15
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.