Reported Mar 8, 2023 · Terminated
Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC…
Accord Healthcare, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Accord Healthcare, Inc. · 1009 Slater Rd Ste 210B · Durham, NC · 27703-8446
Is this the product you have?
- Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only
- Manufactured forAccord Healthcare, Inc., Durham, NC 27703
- Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA NDC 16729-491-12 UPC 3 16729 49112 9
- Lot codes and dates
11 of 11 products
Products covered by this recall # Product as published 1 P2101481 Exp. Date 2/28/2023 2 P2101985, P2101958, P2102019, Exp. Date 3/31/2023 3 P2102580, P2102597, Exp. Date 4/30/2023 4 P2104708, P2104712, Exp. Date 6/30/2023 5 P2107154, P2107187, Exp. Date 10/31/2023 6 P2107874, Exp. Date 11/30/2023 7 P2200772, P2200796, P2200830, Exp. Date 12/31/2023 8 P2201196, P2201198, Exp. Date 1/31/2024 9 P2200817, Exp. Date 12/31/2024 10 P2202610, Exp. Date 4/30/2025 11 P2203466, Exp. Date 5/31/2025 - Amount recalled
- 113,571 bottles
This recall covers 67 products
The agency filed one notice per product. You are reading one of them; the other 66 are below.
54 more are in the archive.
Where it was sold
Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Accord Healthcare, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.