NDC 0713-0656
Clobetasol Propionate 0.5 mg per 1 g ointment
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, tests it, packages it and labels it | Problems found, fixed voluntarilyJul 21, 2023 · 6 inspections |
Recalls
- Jun 2, 2017 · Class III · G & W Laboratories, Inc.
Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.
Lots: Lot #: a) 1001090, Exp 8/ 17; 1002881, Exp 2/18; b) 1001086, Exp 8/ 17; 1001154, Exp 11/ 17; 1001156, Exp 9/17; 1002882, Exp 2/18, 1004564, Exp 7/18; c) 1001155, Exp 9/17; 1004572, Exp 7/18; d) 1001158, Exp 9/17; 1001159, Exp 10/17; 1002884, Exp 4/18
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Clobetasol: every company that makes it
- Form
- ointment, topical
- Strength
- 0.5 mg per 1 g
- Approval
- ANDA ANDA074089
- On the market since
- Jan 4, 2016
- Package NDCs
0713-0656-150713-0656-310713-0656-370713-0656-60- Official label
- DailyMed (National Library of Medicine), updated Nov 28, 2023
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