April 2014 FDA Recall Drug by Pfizer Inc.
D-1253-2014 - Presence of Foriegn Tablets/Capsules

This Class II drug recall was voluntarily initiated by Pfizer Inc. on April 8, 2014 for the product Drug. The FDA reported the reason for recall as presence of foriegn tablets/capsules. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1253-2014

Reason for Recall
Presence of Foriegn Tablets/Capsules: A single Tikosyn¿ (dofetilide) 250 mcg capsule was discovered in one bottle of Tikosyn¿ (dofetilide) 500 mcg (0.5 mg).
Initiated
04-08-2014
Reported
04-30-2014
Quantity
23,064 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67870
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide including Puerto Rico and US Virgin Islands. 65 federal government accounts received the affected product directly from Pfizer Inc
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-24-2017
Product Description About Product Description
Full technical description of the product.
Tikosyn¿ (dofetilide) 500 mcg (0.5mg) capsules, 60-count bottle, Rx only Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, NDC 00069-5820-60

Batch or Lot Expiration Information

Lot# H48496, H48497; Exp 05/15