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
- Jan 19, 2018 · Class III · G & W Laboratories, Inc.
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Lots: Lot #: a) 1002896, Exp 09/18; 1005797, Exp 05/19; 1006100, Exp 07/19; b) 1002561, Exp 06/18; 1002897, Exp 09/18; 1005798, Exp 05/19; 1006101, Exp 07/19; c) 1002898, Exp 10/18; 1004283, Exp 12/18; 1005837, Exp 05/19; 1006321, 1006322, Exp 07/19 - Mar 20, 2017 · Class III · G & W Laboratories, Inc.
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Lots: Lot #: a) 63800090, Exp 04/17; 63800095, Exp 11/17; 1000573, Exp 02/18; 1002560, Exp 06/18; b) 63800090, Exp 04/17; 63800092, Exp 07/17; 63800093, Exp 08/17; 63800095, Exp 11/17; 1000574, Exp 02/18; 1001772, Exp 05/18; c) 63800089, Exp 03/17; 63800091, Exp 07/17; 63800094, Exp 08/17; 1000842, Exp 0…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ciclopirox: every company that makes it
- Form
- cream, topical
- Strength
- 7.7 mg per 1 g
- Approval
- ANDA ANDA078463
- On the market since
- May 22, 2007
- Package NDCs
0713-0638-150713-0638-180713-0638-31- Official label
- DailyMed (National Library of Medicine), updated Nov 16, 2022
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