FDA-Drug2014-12-17Class II
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.
Pfizer Inc.
Hazard
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
Sold states
Pfizer shipped the affected product to 4,447 direct accounts. No federal government accounts received the affected product directly from Pfizer Inc.
Affected count
31,569 HDPE Bottles
Manufactured in
235 East 42nd Street, N/A, New York, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0292-2015Don't want to check this manually?
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