Corticosteroid
Where is Clocortolone made?
4 companies sell it under their own name. Their labels name 2 factories in Israel and the United States.
Israel 1United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Caraco Pharmaceutical Laboratories, Ltd.0.001 g per 1 g · NDC 51672-4166 | Taro Pharmaceutical Industries Ltd.Makes it | Haifa Bay, Israel | No problems foundDec 2022 |
| Dr. Reddy's Laboratories Inc.0.001 g per 1 g · NDC 43598-341 | DPT Laboratories, Ltd.Makes it and tests it | San Antonio, TX, United States | No problems foundMay 2024 |
| EPI Health, Inc Cloderm1 mg per 1 g · NDC 71403-804 | EPI Health, IncMakes it | Location not on file | Not inspected on record |
| Promius Pharma, LLC. Cloderm0.001 g per 1 g · NDC 67857-804 | DPT Laboratories, Ltd.Makes it | San Antonio, TX, United States | No problems foundMay 2024 |
Recalls
- Apr 23, 2024 · Class II · EPI Health, LLC
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess. - Mar 8, 2018 · Class III · Dr. Reddy's Laboratories, Inc.
Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.