Cystine Depleting Agent
Where is Cysteamine made?
4 companies sell it under their own name. Their labels name 1 factory in Switzerland.
Switzerland 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Recordati Rare Diseases, Inc. Cystadrops3.5 mg per 1 mL · NDC 55292-410 | Baccinex SAMakes it | Courroux, Switzerland | Problems found, fixed voluntarilyJun 2024 |
| Horizon Therapeutics USA, Inc. Procysbi25 mg, 75 mg, 300 mg · NDC 75987-100, 75987-145, 75987-101 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Leadiant Biosciences, Inc. Cystaran6.5 mg per 1 mL · NDC 54482-020, 54482-035 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc. Cystagon50 mg, 150 mg · NDC 0378-9045, 0378-9040 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Sep 24, 2020 · Class III · Leadiant Biosciences, Inc.
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl. - Apr 9, 2018 · Class III · Leadiant Biosciences, Inc
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride. - Feb 14, 2018 · Class III · Leadiant Biosciences, Inc
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.