Prescription drug
Where is Prasterone 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 |
|---|---|---|---|
| AMAG Pharmaceuticals, Inc. Intrarosa6.5 mg · NDC 64011-601 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Millicent US, Inc. Intrarosa6.5 mg · NDC 72495-501, 72495-401 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.