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.
Reason for recall: Failed Dissolution Specifications: Out of specification for dissolution.
Recall initiated: 20240205
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated