Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | Serious problems, FDA actionDec 2, 2022 · 7 inspections, 1 with FDA action |
Recalls
- Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: P2202518, P2202512, Exp. Date 4/30/2024, P2204588, P2204589, Exp. Date 7/31/2024 - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: P2202519, P2202513 Exp. Date 4/30/2024
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Pirfenidone: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 801 mg
- Approval
- ANDA ANDA212730
- On the market since
- May 27, 2022
- Package NDCs
16729-468-1516729-468-64- Official label
- DailyMed (National Library of Medicine), updated Dec 17, 2025
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?