Reported Mar 8, 2023 · Terminated
Dofetilide Capsules 500 mcg (0.5 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 500 mcg (0.5 mg)60-count bottleRx only
- Manufactured forAccord Healthcare, Inc., Durham, NC 27703
- Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA NDC 16729-492-12 UPC 3 16729 49212 6
- Lot codes and dates
8 of 8 products
Products covered by this recall # Product as published 1 P2101582, P2101661, P2101482, P2101686, Exp. Date 2/28/2023 2 P2102581, P2102598, Exp. Date 4/30/2023 3 P2103623, P2103653, P2103670, Exp. Date 5/31/2023 4 P2104463, P2104385, P2104386, P2104472, P2104709, P2104714, Exp. Date 6/30/2023 5 P2200797, P2200773, P2200831, Exp. Date 12/31/2023 6 P2201017, P2201081, P2201056, Exp. Date 1/31/2024 7 P2200819, Exp. Date 12/31/2024 8 P2202611, P2202616, Exp. Date 4/30/2025, P2203467, Exp. Date 5/31/2025 - Amount recalled
- 113,003 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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