NDC 69189-5810
Tikosyn 0.25 mg capsule
On the label: Avera McKennan Hospital. It's repackaged: Avera McKennan Hospital rebottles it from Pfizer Laboratories Div Pfizer Inc's NDC 0069-5810.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Pfizer Ireland Pharmaceuticals Unlimited Company | Ringaskiddy, Ireland | Makes the active ingredient and tests it | Problems found, fixed voluntarilyOct 25, 2024 · 6 inspections |
| Pfizer Italia S.r.l. | Ascoli Piceno, Italy | Makes it, tests it and packages it | Problems found, fixed voluntarilyMar 14, 2025 · 5 inspections |
Repackaging site
- Avera McKennan Hospital, Location not on file · repackages it and relabels it
Recalls
- Dec 3, 2014 · Class II · Pfizer Inc.
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
Lots: Lot # a) H79652, Exp. 10/15; b) H79653, Exp. 10/15
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Dofetilide: every company that makes it
- Form
- capsule
- Strength
- 0.25 mg
- Approval
- NDA NDA020931
- On the market since
- Jul 29, 2016
- Package NDCs
69189-5810-1- Official label
- DailyMed (National Library of Medicine), updated Mar 29, 2017
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