Reported Mar 29, 2023 · Terminated
Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries…
Sun Pharmaceutical Industries Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620
Is this the product you have?
- Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only
- Manufactured bySun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 47335-0063-86
- Lot codes and dates
Lot # DND1541AExp 08/2024
- Amount recalled
- 1,920 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Content Uniformity Specifications
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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