FDAFDA · Food and drugs·Recall number D-0474-2023
Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 47335-0063-86
Published March 29, 2023 · Recall initiated: March 9, 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
Failed Content Uniformity Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Distributor
- USA nationwide.
- Lot
- Lot # DND1541A, Exp 08/2024
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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