Mallinckrodt Pharmaceuticals
Overview
Mallinckrodt Pharmaceuticals is a global specialty pharmaceutical company that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies. The company focuses on areas with high unmet medical needs, such as autoimmune and rare diseases as well as providing a variety of pain management solutions.
Therapeutic areas
API / Drug Master Files
Mallinckrodt Pharmaceuticals holds 1 active (1 total) FDA Type II Drug Master File — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- H.P. ACTHAR GEL (REPOSITORY CORTICOTROPIN INJECTION)Active2011-09-28
FDA compliance signals
2 FDA enforcement records linked to this company.
- recall — Class II2019-05-29
Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
- recall — Class II2019-05-29
Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
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