Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Ajanta Pharma Limited | Bharuch, India | Makes it | No problems foundJun 23, 2023 · 3 inspections |
Recalls
- Aug 25, 2026 · Class III · Ajanta Pharma USA Inc
Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.
Lots: Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Fluphenazine: every company that makes it
- Form
- tablet, oral
- Strength
- 10 mg
- Approval
- ANDA ANDA217410
- On the market since
- Jan 5, 2023
- Package NDCs
27241-252-01- Official label
- DailyMed (National Library of Medicine), updated Nov 4, 2025
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