NDC 0713-0223
Fluocinolone Acetonide 0.1 mg per 1 g cream
On the label: Cosette Pharmaceuticals, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Cosette Pharmaceuticals NC Laboratories, LLC | Lincolnton, NC, United States | Makes it | Problems found, fixed voluntarilyJul 21, 2023 · 6 inspections |
Recalls
- Sep 30, 2013 · Class III · G & W Laboratories Inc
Failed Content Uniformity Specifications; at the 18 month time point.
Lots: 15 gm Lot #: 022211002, 022212001- 022212008, 022212010-022212012, 022212017, 022213001, 022213005, 022213008 60 gm Lot #: 022211002, 022212001- 022212007, 022212009, 022212010, 022212012-022212016, 022212018, 022212019, 022213002.
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
- cream, topical
- Strength
- 0.1 mg per 1 g
- Approval
- ANDA ANDA089526
- On the market since
- Jul 26, 1988
- Package NDCs
0713-0223-150713-0223-60- Official label
- DailyMed (National Library of Medicine), updated Nov 22, 2023
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