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.
D-0292-2015
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 69724
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31,569 HDPE Bottles
- Official record key
drug-enforcement:D-0292-2015
Official wording
Reason: Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
Code information: Lot # a) H79652, Exp. 10/15; b) H79653, Exp. 10/15
Distribution pattern: Pfizer shipped the affected product to 4,447 direct accounts. No federal government accounts received the affected product directly from Pfizer Inc.
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.