NDC 63304-089
Mesalamine 500 mg capsule, extended release
On the label: Caraco Pharmaceutical Laboratories, Ltd..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | Mohali, India | Makes it | Serious problems, FDA actionAug 12, 2022 · 7 inspections, 2 with FDA action |
Recalls
- Feb 5, 2024 · Class II · Sun Pharmaceutical Industries Inc
Failed Dissolution Specifications: Out of specification for dissolution.
Lots: 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, MHD…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Mesalamine: every company that makes it
- Form
- capsule, extended release, oral
- Strength
- 500 mg
- Approval
- ANDA ANDA214585
- On the market since
- May 13, 2022
- Package NDCs
63304-089-13- Official label
- DailyMed (National Library of Medicine), updated Aug 27, 2024
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