Recall: D-0350-2024

Class II - Potentially Harmful

Class IIClassification

2024-02-05Initiated

OngoingStatus

SUN PHARMACEUTICAL INDUSTRIES Firm

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

Failed Dissolution Specifications: Out of specification for dissolution.

Distribution

Nationwide in the U.S.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.