Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61), b) 60-count bottl...
FDA Recall #D-0292-2015 — Class II — December 3, 2014
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.
Reason for Recall
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
Recalling Firm
Pfizer Inc. — New York, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product 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.
Code Information
Lot # a) H79652, Exp. 10/15; b) H79653, Exp. 10/15
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated