Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | No problems foundJul 12, 2024 · 10 inspections |
| 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: P2005583, P2005584, P2005585, P2005527, P2005528, P2005586, Exp. Date 9/30/2023; P2005980, Exp. Date 10/31/2023; P2100396, P2100264, P2100263, Exp. Date 12/31/2023; P2101583, P2101711, P2101708, P2101584, Exp. Date 2/29/2024; P2102852, P2102851, P2102853, P2102854, P2102855, Exp. Date 4/30…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Finasteride: every company that makes it
- Form
- tablet, film coated
- Strength
- 1 mg
- Approval
- ANDA ANDA091643
- On the market since
- Jun 12, 2019
- Package NDCs
71713-096-90- Official label
- DailyMed (National Library of Medicine), updated Nov 7, 2022
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