Corticosteroid
Where is Hydrocortisone and Pramoxine made?
7 companies sell it under their own name and 2 repackagers rebottle it. Their labels name 4 factories in the United States.
United States 4
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Sebela Pharmaceuticals Inc.10 mg per 1 g, 10 mg per 1 g / 25 mg per 1 g, 10 mg per 1 mL, 10 mg per 1 mL / 25 mg per 1 mL · NDC 54766-778, 54766-716, 54766-763 +5 | Ferndale Laboratories, Inc.Makes it, tests it, packages it and labels it | Ferndale, MI, United States | Problems found, fixed voluntarilyFeb 2026 |
| W. R. Grace & Co.-Conn.Makes the active ingredient | South Haven, MI, United States | No problems foundMar 2026 | |
| TruPharma LLC.1 g per 100 g / 2.5 g per 100 g · NDC 52817-817 | Saptalis Pharmaceuticals LLCMakes it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMar 2026 |
| Womens Choice Pharmaceuticals LLC11.5 mg per 1 g / 18.5 mg per 1 g · NDC 50967-357 | Span Packaging Services LLC dba Multi-Pack SolutionsMakes it | Greenville, SC, United States | Problems found, fixed voluntarilyMay 2025 |
| Legacy Pharma USA, Inc.10 mg per 1 g, 10 mg per 1 g / 25 mg per 1 g, 10 mg per 1 mL, 10 mg per 1 mL / 25 mg per 1 mL · NDC 83107-018, 83107-017, 83107-016 +6 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis Israel Pharmaceuticals Ltd1 g per 100 g, 1 g per 100 g / 2.5 g per 100 g · NDC 45802-144, 45802-472, 45802-124 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pageview Pharmaceuticals18 mg / 25 mg · NDC 73028-401 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Viatris Specialty LLC100 mg per 10 g · NDC 0037-6824, 0037-6822 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Hydrocortisone and Pramoxine in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- Bryant Ranch Prepack:
72162-1399,63629-8669,63629-8674,63629-8673+9 - Rebel Distributors Corp..:
21695-982
Recalls
- Jan 21, 2022 · Class II · Mylan Pharmaceuticals Inc
cGMP deficiencies - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.