Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | Serious problems, FDA actionDec 2, 2022 · 7 inspections, 1 with FDA action |
Recalls
- Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: P2101480, Exp. Date 2/28/2023; P2102579, P2102596, Exp. Date 4/30/2023; P2104711, P2104707, Exp. Date 6/30/2023; P2200771, P2200829, P2200795, Exp. Date 12/31/2023; P2202608, Exp. Date 4/30/2025; P2203492, P2203463, Exp. Date 5/31/2025; P2205373, P2205412, Exp. Date 8/31/2025; - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: P2101481 Exp. Date 2/28/2023; P2101985, P2101958, P2102019, Exp. Date 3/31/2023; P2102580, P2102597, Exp. Date 4/30/2023; P2104708, P2104712, Exp. Date 6/30/2023; P2107154, P2107187, Exp. Date 10/31/2023; P2107874, Exp. Date 11/30/2023; P2200772, P2200796, P2200830, Exp. Date 12/31/2023… - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: P2101582, P2101661, P2101482, P2101686, Exp. Date 2/28/2023; P2102581, P2102598, Exp. Date 4/30/2023; P2103623, P2103653, P2103670, Exp. Date 5/31/2023; P2104463, P2104385, P2104386, P2104472, P2104709, P2104714, Exp. Date 6/30/2023; P2200797, P2200773, P2200831, Exp. Date 12/31/2023; P22…
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, oral
- Strength
- 0.125 mg
- Approval
- ANDA ANDA213338
- On the market since
- Aug 20, 2020
- Package NDCs
16729-490-1216729-490-59- Official label
- DailyMed (National Library of Medicine), updated Oct 9, 2025
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