FDAFDA · Food and drugs·Recall number D-1082-2023
Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T of D & NH), India, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512. NDC 47335-063-86
Published August 16, 2023 · Recall initiated: July 18, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Out of Specification result observed in content uniformity testing
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DOFETILIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Distributor
- Nationwide in the USA
- UPC
- 0347335062861
- Lot
- Lot: DNE0217A, Exp 01/2025
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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