Prescription drug
Where is Inotersen 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 |
|---|---|---|---|
| Akcea Therapeutics, Inc. Tegsedi284 mg per 1.5 mL · NDC 72126-007 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Catalent Indiana, LLC284 mg per 1.5 mL · NDC 61434-031 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- May 23, 2022 · Class I · Akcea Therapeutics, Inc.
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.