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.
Recall Number: D-0292-2015
Firm: Pfizer Inc.
Classification: Class II
Status: Terminated
Report Date: 20141217
Initiation Date: 20141203
Termination Date: 20160927
Reason for Recall
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.