Class II
Terminated
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.
This recall has been terminated (originally issued December 17, 2014).
- Company
- Pfizer Inc.
- Recall Initiated
- December 3, 2014
- Posted
- December 17, 2014
- Recall Number
- D-0292-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 31,569 HDPE Bottles
- Firm Location
- New York, NY, United States
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot # a) H79652, Exp. 10/15; b) H79653, Exp. 10/15
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