Adrenocorticotropic Hormone
Where is Corticotropin made?
2 companies sell it under their own name. None of their labels names the factory.
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| ANI Pharmaceuticals, Inc. Purified Cortrophin Gel80 [USP'U] per 1 mL · NDC 62559-860, 62559-861 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Keenova ARD LLC Acthar40 [USP'U] per 0.5 mL, 80 [USP'U] per 1 mL · NDC 63004-8712, 63004-8710, 63004-8711 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Aug 6, 2026 · Class II · Mallinckrodt Hospital Products Inc.
Presence of particulate matter: glass and stopper piece - Feb 6, 2024 · Class II · Mallinckrodt Hospital Products Inc.
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.