Pfizer Inc. recalls Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61), b) 60-count bottle (NDC 0069-5800-60), R

Recalled December 17, 2014 · FDA recall D-0292-2015 · Pfizer

Hazard

Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules. · FDA Class II

Units

31,569 HDPE Bottles

Sold at

Pfizer shipped the affected product to 4,447 direct accounts. No federal government accounts received the affected product directly from Pfizer Inc.

Description

Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.

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.

Manufacturer(s)

Pfizer Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →