NDC 63304-175
Mesalamine 1.2 g tablet, delayed release
On the label: Caraco Pharmaceutical Laboratories, Ltd..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | Dadra, India | Makes it | Problems found, fixed voluntarilyMar 29, 2019 · 5 inspections |
| Sun Pharmaceutical Industries Limited | Ahilyanagar (formerly known as Ahmednagar), India | Makes the active ingredient | No problems foundSep 11, 2026 · 6 inspections |
Recalls
- Jan 18, 2024 · Class II · Sun Pharmaceutical Industries Inc
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lots: Lot #s: DNE0875A Exp. 01/31/2025; DNE0876A, DNE0877A, DNE1080A, DNE1081A Exp. 02/28/2025; DNE1147A, DNE1148A Exp. 03/31/2025.
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
- tablet, delayed release, oral
- Strength
- 1.2 g
- Approval
- ANDA ANDA211858
- On the market since
- Feb 1, 2019
- Package NDCs
63304-175-13- Official label
- DailyMed (National Library of Medicine), updated Dec 1, 2023
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