FDA-Drug2023-08-16Class III
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
SUN PHARMACEUTICAL INDUSTRIES INC
Hazard
Out of Specification result observed in content uniformity testing
Sold states
Nationwide in the USA
Affected count
360 60-count bottles
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1082-2023Don't want to check this manually?
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