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.