NDC 62541-405
Pancreaze 21000 [USP'U] / 54700 [USP'U] / 83900 [USP'U] capsule, delayed release
On the label: Vivus LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Nordmark Pharma GmbH | Uetersen, Germany | Makes it, makes the active ingredient and tests it | Problems found, fixed voluntarilyFeb 13, 2025 · 8 inspections |
Recalls
- Jun 23, 2023 · Class III · Vivus, Inc.
Failed Stability Specifications
Lots: Lot #: 102101, Exp: 31 July 2024
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Pancrelipase Amylase and Pancrelipase Lipase and Pancrelipase Protease: every company that makes it
- Form
- capsule, delayed release, oral
- Strength
- 21000 [USP'U] / 54700 [USP'U] / 83900 [USP'U]
- Approval
- BLA BLA022523
- On the market since
- Apr 12, 2010
- Package NDCs
62541-405-10- Official label
- DailyMed (National Library of Medicine), updated Jun 6, 2025
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