FDA recall D-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

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).

Distribution

US Nationwide including Puerto Rico and US Virgin Islands. 65 federal government accounts received the affected product directly from Pfizer Inc

Key facts

Status

Terminated

Initiation date

2014-04-08

Report date

2014-04-30

Termination date

2017-04-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

N/A

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1253-2014