FDA recall D-0292-2015

Pfizer Inc. · Class II · drug

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 Labs, Division of Pfizer, Inc., NY, NY 10017.

Reason for recall

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

Distribution

Pfizer shipped the affected product to 4,447 direct accounts. No federal government accounts received the affected product directly from Pfizer Inc.

Key facts

Status: Terminated
Initiation date: 2014-12-03
Report date: 2014-12-17
Termination date: 2016-09-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0292-2015