FDA Drug Class II — Moderate

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.

Hazard

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

Products

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.
Brand
Pfizer Inc.
UPC
Lot # a) H79652, Exp. 10/15; b) H79653, Exp. 10/15

Units Affected

31,569 HDPE Bottles