NDC 69189-0189
Pentasa 250 mg capsule
On the label: Avera McKennan Hospital. It's repackaged: Avera McKennan Hospital rebottles it from Takeda Pharmaceuticals America, Inc.'s NDC 54092-189.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Patheon Manufacturing Services LLC | Greenville, NC, United States | Makes it, tests it, packages it and labels it | No problems foundSep 26, 2025 · 11 inspections |
| PharmaZell GmbH | Raubling, Germany | Makes the active ingredient | Problems found, fixed voluntarilyJun 30, 2022 · 4 inspections |
| Syntese A/S | Hvidovre, Denmark | Makes the active ingredient and tests it | Problems found, fixed voluntarilyMay 12, 2023 · 3 inspections |
| Sharp Packaging Services, LLC | Allentown, PA, United States | Packages it | No problems foundNov 21, 2025 · 7 inspections |
Repackaging site
- Avera McKennan Hospital, Location not on file · repackages it and relabels it
Recalls
- Dec 2, 2016 · Class III · Shire PLC
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Lots: Lot Number AE7363A, exp 06/30/2019
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
- Strength
- 250 mg
- Approval
- NDA NDA020049
- On the market since
- Apr 27, 2015
- Package NDCs
69189-0189-1- Official label
- DailyMed (National Library of Medicine), updated Jan 5, 2016
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