Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Product description
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
Lot numbers, UPCs & expiration codes
R81339
Where it was sold
FL, GA, SC
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0560-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 15, 2021
- FDA report date
- Jun 2, 2021
- Quantity
- 205 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cardinal Health Inc.
Original FDA data
Every field from FDA enforcement report D-0560-2021, exactly as published.
Show all FDA fields
- City
- Dublin
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 87512
- Address
- 7000 Cardinal Pl
- Code information
- R81339
- Postal code
- 43017-1091
- Report date
- Jun 2, 2021
- Product type
- Drugs
- Recall number
- D-0560-2021
- Classification
- Class II
- Recalling firm
- Cardinal Health Inc.
- Product quantity
- 205 cartons
- Termination date
- Jun 17, 2024
- Reason for recall
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- FL, GA, SC
- Recall initiation date
- Mar 15, 2021
- Initial firm notification
- Letter
- Center classification date
- May 24, 2021