Tikosyn Capsule
FDA Recall NDC 0069-5800
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Tikosyn (NDC 0069-5800). A significant event, classified as Class II, was initiated on Dec 03, 2014 by Pfizer Laboratories Div Pfizer Inc. The reported reason for this action was: "Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
Dec 03, 2014
Dec 17, 2014
31,569 HDPE Bottles
Recall Profile & Regulatory Data
Event ID
69724
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Pfizer shipped the affected product to 4,447 direct accounts. No federal government accounts received the affected product directly from Pfizer Inc.
Termination Date
Sep 27, 2016
Product Description
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
Affected Packages Involved in this Recall
0069-5800-61Product
0069-5800-60Product
0069-5800-43Product
0069-5810-61Product
0069-5810-60Product
0069-5810-43Product
0069-5820-61Product
0069-5820-60Product
0069-5820-43Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
