Drug recall D-0292-2015
Product
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.
Reason for recall
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
Lots and codes
Lot # a) H79652, Exp. 10/15; b) H79653, Exp. 10/15
Recall details
- Recalling firm
- Pfizer Inc., New York, NY
- Quantity
- 31,569 HDPE Bottles
- Distribution
- Pfizer shipped the affected product to 4,447 direct accounts. No federal government accounts received the affected product directly from Pfizer Inc.
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 3, 2014
- Terminated
- September 27, 2016
Related products
- Tikosyn – drug information
- NDC 0069-5810 Tikosyn · Dofetilide .25 mg/1 · Pfizer Laboratories Div Pfizer Inc
- NDC 0069-5820 Tikosyn · Dofetilide .5 mg/1 · Pfizer Laboratories Div Pfizer Inc
- NDC 0069-5800 Tikosyn · Dofetilide .125 mg/1 · Pfizer Laboratories Div Pfizer Inc