December 2014 FDA Recall Tikosyn by Pfizer Inc.
D-0292-2015 - Failed Tablet/Capsule Specifications
This Class II drug recall was voluntarily initiated by Pfizer Inc. on December 3, 2014 for the product Tikosyn. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed in Pfizer shipped the affected product to 4,447 direct accounts. No federal government accounts received the affected product directly from Pfizer Inc. and the recall is currently terminated.
Recall Number: D-0292-2015
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
12-03-2014
12-17-2014
31,569 HDPE Bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Pfizer shipped the affected product to 4,447 direct accounts. No federal government accounts received the affected product directly from Pfizer Inc.
09-27-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of 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.
Batch or Lot Expiration Information
Lot# a) H79652, Exp. 10/15; b) H79653, Exp. 10/15
