Intrarosa Prasterone Vaginal Inserts 6.5 mg 28 inserts/applicators Rx Only Manufactured…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
What was recalled
Intrarosa Prasterone Vaginal Inserts 6.5 mg 28 inserts/applicators Rx Only Manufactured for: Ednoceutics, Inc. Quebec City, Canada, G1V 4M7 Distributed by: AMAG Pharmaceuticals, Inc. Waltam, MA 02451, NDC 64011-601-28
- Recalling firm
- Cardinal Health Inc.
- NDC code
- 64011-601-28
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0560-2021
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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