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.

FDA recall notice · announced December 17, 2014 · Pfizer

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

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

Notes

Distribution: Pfizer shipped the affected product to 4,447 direct accounts. No federal government accounts received the affected product directly from Pfizer Inc.
Lot/code information: Lot # a) H79652, Exp. 10/15; b) H79653, Exp. 10/15
Quantity: 31,569 HDPE Bottles
Status: Terminated
Products in this recall event:
- 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. (D-0292-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.