FDAFDA · Food and drugs·Recall number D-1253-2014
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
Published April 30, 2014 · Recall initiated: April 8, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Pfizer Inc.
- Distributor
- US Nationwide including Puerto Rico and US Virgin Islands. 65 federal government accounts received the affected product directly from Pfizer Inc
- Lot
- H48496, H48497; Exp 05/15
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- US
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