SUN PHARMACEUTICAL INDUSTRIES INC recalls Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical I
Recalled March 6, 2024 · FDA recall D-0350-2024 · SUN PHARMACEUTICAL INDUSTRIES
Hazard
Failed Dissolution Specifications: Out of specification for dissolution. · FDA Class II
Units
54,960 bottles
Sold at
Nationwide in the U.S.
Description
Failed Dissolution Specifications: Out of specification for dissolution.
Product
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.
Manufacturer(s)
SUN PHARMACEUTICAL INDUSTRIES INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →