Drug product
Tikosyn¿ (dofetilide) 500 mcg (0.5mg) capsules, 60-count bottle, Rx only Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, NDC 00069-5820-60
D-1253-2014
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 67870
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23,064 bottles
- Official record key
drug-enforcement:D-1253-2014
Official wording
Reason: Presence of Foriegn Tablets/Capsules: A single Tikosyn¿ (dofetilide) 250 mcg capsule was discovered in one bottle of Tikosyn¿ (dofetilide) 500 mcg (0.5 mg).
Code information: H48496, H48497; Exp 05/15
Distribution pattern: US Nationwide including Puerto Rico and US Virgin Islands. 65 federal government accounts received the affected product directly from Pfizer Inc
Derived failure modes
-
Unknown
Presence of Foriegn Tablets/Capsules: A single Tikosyn¿ (dofetilide) 250 mcg capsule was discovered in one bottle of Tikosyn¿ (dofetilide) 500 mcg (0.5 mg).