Corticosteroid
Where is Acetic Acid and Hydrocortisone made?
4 companies sell it under their own name. Their labels name 2 factories in Canada and the United States.
Canada 1United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Akorn hydrocortisone and acetic acid20.75 mg per 1 mL / 10.375 mg per 1 mL · NDC 50383-901 | AkornMakes it | Location not on file | Not inspected on record |
| Caraco Pharmaceutical Laboratories, Ltd.10.4 mg per 1 mL / 20.8 mg per 1 mL · NDC 51672-3007 | Sun Pharma Canada Inc.Makes it | Brampton, Canada | No problems foundMar 2026 |
| Cosette Pharmaceuticals, Inc.10 mg per 1 mL / 20 mg per 1 mL · NDC 0713-0849 | Cosette Pharmaceuticals NC Laboratories, LLCMakes it, tests it, packages it and labels it | Lincolnton, NC, United States | Problems found, fixed voluntarilyJul 2023 |
| Saptalis Pharmaceuticals, LLC.20.75 mg per 1 mL / 10.375 mg per 1 mL · NDC 71656-064 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Aug 7, 2024 · Class III · Taro Pharmaceuticals U.S.A., Inc.
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing. - Nov 6, 2023 · Class III · Taro Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing. - Dec 16, 2019 · Class II · Akorn Inc
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product. - Mar 12, 2019 · Class II · Akorn Inc
Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature. - Aug 21, 2015 · Class III · Akorn, Inc.
Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consi…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.