NDC 54868-3408
Fluocinonide 0.5 mg per 1 g cream
On the label: Physicians Total Care, Inc.. It's repackaged: Physicians Total Care, Inc. rebottles it from Caraco Pharmaceutical Laboratories, Ltd.'s NDC 51672-1253.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharma Canada Inc. | Brampton, Canada | Makes it | No problems foundMar 27, 2026 · 7 inspections |
Repackaging site
- Physicians Total Care, Inc., Tulsa, Oklahoma, United States · relabels it
Recalls
- Sep 20, 2017 · Class III · Taro Pharmaceuticals U.S.A., Inc.
Cross contamination with other products: traces of Dapsone were found in the finished product.
Lots: Lot #: A771026850, Exp 6/18 - Mar 17, 2017 · Class III · Taro Pharmaceuticals U.S.A., Inc.
Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.
Lots: Lot #: D301311473, D301411473, Exp 3/2017
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Fluocinonide: every company that makes it
- Form
- cream
- Strength
- 0.5 mg per 1 g
- Approval
- NDA NDA019117
- On the market since
- Jun 26, 1984
- Package NDCs
54868-3408-054868-3408-1- Official label
- DailyMed (National Library of Medicine), updated Apr 21, 2014
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