D-0350-2024 Class II Ongoing
FDA drug recall D-0350-2024 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on Feb 5, 2024 and is designated Class II. Reason for recall: Failed Dissolution Specifications: Out of specification for dissolution. The recall status is ongoing. Affected quantity: 54,960 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 6, 2024
- Initiation Date
- Feb 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 54,960 bottles
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.
Reason for Recall
Failed Dissolution Specifications: Out of specification for dissolution.
Distribution Pattern
Nationwide in the U.S.
Code Information
Lot #s: MHD0606A, MHD0612A, Exp. 04/30/2024; MHD0613A, MHD0652A, MHD0657A, MHD0672A, MHD0673A, Exp. 05/31/2024; MHD0767A, MHD0768A, MHD0769A, MHD0785A, MHD0799A, MHD0800A, MHD0801A, Exp. 06/30/2024; MHD0827A, MHD0828A, MHD0875A, MHD0876A, MHD0898A, MHD0901A, Exp. 07/31/2024; MHD1081A, MHD1082A, MHD1087A Exp. 09/30/2024.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0350-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026