Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Bora Pharmaceutical Laboratories Inc. | Zhunan Township, Taiwan | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyJul 21, 2025 · 7 inspections |
Recalls
- Mar 17, 2016 · Class III · Impax Laboratories, Inc.
Labeling: Incorrect or Missing Lot and/or Exp. Date
Lots: Lot # 10008320; Exp. 05/16 Lot # 10008744, 10008974; Exp. 11/16 Lot # 10009342; Exp. 03/17 Lot # 10010202; Exp. 09/17 Lot # 20001416A; Exp. 10/17 Lot # 20001557A; Exp. 01/18 Lot # 20001675A; Exp. 03/18 Lot # 20001831A; Exp. 06/18
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Fenofibric Acid: every company that makes it
- Form
- capsule
- Strength
- 200 mg
- Approval
- ANDA ANDA075868
- On the market since
- Feb 1, 2010
- Package NDCs
0115-0533-010115-0533-02- Official label
- DailyMed (National Library of Medicine), updated Sep 7, 2022
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