NDC 51672-1365
Fluocinolone Acetonide 0.1 mg per 1 mL solution
On the label: Caraco Pharmaceutical Laboratories, Ltd..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharma Canada Inc. | Brampton, Canada | Makes it | No problems foundMar 27, 2026 · 7 inspections |
Recalls
- Dec 30, 2025 · Class III · Sun Pharmaceutical Industries Inc
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Lots: Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Fluocinolone Acetonide: every company that makes it
- Form
- solution, topical
- Strength
- 0.1 mg per 1 mL
- Approval
- ANDA ANDA089124
- On the market since
- Mar 27, 2015
- Package NDCs
51672-1365-251672-1365-4- Official label
- DailyMed (National Library of Medicine), updated Jul 3, 2025
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