Reported Dec 17, 2014 · Terminated

Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61), b) 60-count bottle (NDC 0069-5800-60),…

Pfizer Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Pfizer Inc. · 235 East 42nd Street · New York, NY · 10017-5703

Is this the product you have?

  • 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.
Lot codes and dates
    • Lot # a) H79652
    • Exp. 10/15
    • b) H79653
    • Exp. 10/15
Amount recalled
31,569 HDPE Bottles

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 27, 2016 · Data as of Sep 19, 5:03 PM UTC

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