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).
Product description
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
Lot numbers, UPCs & expiration codes
H48496, H48497; Exp 05/15
Where it was sold
US Nationwide including Puerto Rico and US Virgin Islands. 65 federal government accounts received the affected product directly from Pfizer Inc
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1253-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 8, 2014
- FDA report date
- Apr 30, 2014
- Quantity
- 23,064 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-1253-2014, exactly as published.
Show all FDA fields
- Status
- Terminated
- Event ID
- 67870
- Code information
- H48496, H48497; Exp 05/15
- Report date
- Apr 30, 2014
- Product type
- Drugs
- Recall number
- D-1253-2014
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 23,064 bottles
- Termination date
- Apr 24, 2017
- Reason for recall
- 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).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- US Nationwide including Puerto Rico and US Virgin Islands. 65 federal government accounts received the affected product directly from Pfizer Inc
- Recall initiation date
- Apr 8, 2014
- Initial firm notification
- Letter
- Center classification date
- Apr 22, 2014