PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: April 30, 2014 Initiated: April 8, 2014 #D-1253-2014

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

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).

Details

Recalling Firm
Pfizer Inc.
Units Affected
23,064 bottles
Distribution
US Nationwide including Puerto Rico and US Virgin Islands. 65 federal government accounts received the affected product directly from Pfizer Inc
Location
N/A

Frequently Asked Questions

What product was recalled?
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. Recalled by Pfizer Inc.. Units affected: 23,064 bottles.
Why was this product 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).
Which agency issued this recall?
This recall was issued by the FDA Drug on April 30, 2014. Severity: Moderate. Recall number: D-1253-2014.