Reported Aug 16, 2023 · Terminated
Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited,…
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 (0.5mg), 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 bySun Pharmaceutical Industries, Inc. Cranbury, NJ 08512. NDC 47335-063-86
- Lot codes and dates
- Lot
DNE0217AExp 01/2025
- Lot
- Amount recalled
- 360 60-count bottles
Where it was sold
- Nationwide
Why it was recalled
Out of Specification result observed in content uniformity testing
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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