Recalls / Class II
Class IID-1253-2014
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
- Affected lot / code info
- H48496, H48497; Exp 05/15
Why it was recalled
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).
Recalling firm
- Firm
- Pfizer Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- N/A, N/A, N/A N/A
Distribution
- Quantity
- 23,064 bottles
- Distribution pattern
- US Nationwide including Puerto Rico and US Virgin Islands. 65 federal government accounts received the affected product directly from Pfizer Inc
Timeline
- Recall initiated
- 2014-04-08
- FDA classified
- 2014-04-22
- Posted by FDA
- 2014-04-30
- Terminated
- 2017-04-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1253-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.