FDA-Drug2023-03-29Class III
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
SUN PHARMACEUTICAL INDUSTRIES INC
Hazard
Failed Content Uniformity Specifications
Sold states
USA nationwide.
Affected count
1,920 bottles
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0474-2023Don't want to check this manually?
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