FDAClass IIDecember 17, 2014

Tikosyn recall

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…

Why was Tikosyn recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # a) H79652, Exp. 10/15; b) H79653, Exp. 10/15

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…
Recalling firm
Pfizer Inc.
Quantity
31,569 HDPE Bottles
Distribution
Pfizer shipped the affected product to 4,447 direct accounts. No federal government accounts received the affected product directly from Pfizer Inc.
Recall date
December 17, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls