FDA-Drug2024-03-06Class II
Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 63304-089-13.
Hazard
Failed Dissolution Specifications: Out of specification for dissolution.
Sold states
Nationwide in the U.S.
Affected count
54,960 bottles
Manufactured in
2 Independence Way, Princeton, NJ, United States
Products
Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 63304-089-13.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0350-2024More SUN PHARMACEUTICAL INDUSTRIES INC recalls
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