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.
Reported: December 17, 2014 Initiated: December 3, 2014 #D-0292-2015
Product Description
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.
Details
- Recalling Firm
- Pfizer Inc.
- Units Affected
- 31,569 HDPE Bottles
- Distribution
- Pfizer shipped the affected product to 4,447 direct accounts. No federal government accounts received the affected product directly from Pfizer Inc.
- Location
- New York, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Pfizer Inc.. Units affected: 31,569 HDPE Bottles.
Why was this product recalled? ▼
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 17, 2014. Severity: Moderate. Recall number: D-0292-2015.
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