NDC 43386-069
Fluocinolone Acetonide 0.1 mg per 1 mL solution
On the label: Lupin Pharmaceuticals, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Novel Laboratories, Inc. | Somerset, NJ, United States | Makes it, tests it and packages it | Problems found, fixed voluntarilyApr 17, 2026 · 15 inspections, 1 with FDA action |
Recalls
- Jan 15, 2019 · Class II · Lupin Somerset
Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.
Lots: Lot #: S700214, Exp Apr-19; S700447, Exp Jun-19; S700787, Exp Oct-19; S701057, Exp Nov-19; S800107, Exp Feb-20; S800266, Exp Mar-20; S800524, Exp May-20; S800791, Exp Jul-20 - Oct 5, 2018 · Class II · Lupin Somerset
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
Lots: Lot# M16666, EXP 12/2018 - Feb 22, 2017 · Class III · Novel Laboratories, Inc.
Chemical Contamination
Lots: Lot # M15496; Exp. 10/17 Lot # M15507; Exp. 12/17
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 ANDA206422
- On the market since
- Sep 2, 2015
- Package NDCs
43386-069-60- Official label
- DailyMed (National Library of Medicine), updated Feb 21, 2019
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