Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Immacule Lifesciences Private Limited | Solan, India | Makes it | Serious problems, FDA actionSep 18, 2025 · 3 inspections, 1 with FDA action |
Recalls
- Oct 31, 2025 · Class II · Cipla Limited
Failed Stability Specifications: Observed OOS results: eg results for colour index
Lots: Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Phytonadione: every company that makes it
- Form
- injection, emulsion, intramuscular; intravenous; subcutaneous
- Strength
- 10 mg per 1 mL
- Approval
- ANDA ANDA214596
- On the market since
- Apr 27, 2022
- Package NDCs
69097-708-96- Official label
- DailyMed (National Library of Medicine), updated Jul 12, 2024
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