Recalls / Class II
Class IID-0292-2015
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.
- Brand name
- Tikosyn
- Generic name
- Dofetilide
- Active ingredient
- Dofetilide
- Route
- Oral
- NDCs
- 0069-5800, 0069-5810, 0069-5820
- FDA application
- NDA020931
- Affected lot / code info
- Lot # a) H79652, Exp. 10/15; b) H79653, Exp. 10/15
Why it was recalled
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 31,569 HDPE Bottles
- Distribution pattern
- Pfizer shipped the affected product to 4,447 direct accounts. No federal government accounts received the affected product directly from Pfizer Inc.
Timeline
- Recall initiated
- 2014-12-03
- FDA classified
- 2014-12-09
- Posted by FDA
- 2014-12-17
- Terminated
- 2016-09-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0292-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.