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.

Recall Number: D-0350-2024

Firm: SUN PHARMACEUTICAL INDUSTRIES INC

Classification: Class II

Status: Ongoing

Report Date: 20240306

Initiation Date: 20240205

Termination Date:

Reason for Recall

Failed Dissolution Specifications: Out of specification for dissolution.

Product Description

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.

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Data source: openFDA · Updated regularly