Reported Mar 8, 2023 · Terminated
Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham,…
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, 125 mcg (0.125 mg), 60-count bottle, Rx only
- Manufactured forAccord Healthcare, Inc., Durham, NC 27703
- Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-490-12 UPC 3 16729 49012 2
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 P2101480, Exp. Date 2/28/2023 2 P2102579, P2102596, Exp. Date 4/30/2023 3 P2104711, P2104707, Exp. Date 6/30/2023 4 P2200771, P2200829, P2200795, Exp. Date 12/31/2023 5 P2202608, Exp. Date 4/30/2025 6 P2203492, P2203463, Exp. Date 5/31/2025 7 P2205373, P2205412, Exp. Date 8/31/2025 - Amount recalled
- 37,790 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.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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