Why it was recalled
Lack of sterility assurance
Product description
Milrinone (a) 104MG IN 0.45% NS 130ML,(b) 108MG IN 0.45% NS 135ML, (c) 120MG IN 0.45% NS 150ML, (d) 136MG IN 0.45% NS 170ML, (e) 144MG IN 0.45% NS 180ML, (f) 160MG IN 0.45% NS 200ML, (g) 168MG IN 0.45% NS 210ML, (h) 192MG IN 0.45% NS 240ML, (i) 44MG IN 0.45% NS 55 ML, (j) 52MG IN 0.45% NS 65ML, (k) 56MG IN 0.45% NS 70ML, (l) 68MG IN 0.45% NS 85ML, (m) 84MG IN 0.45% NS 105ML, (n) 88MG IN 0.45% NS 110ML, (o) 92MG IN 0.45% NS 115ML, (p) 96MG IN 0.45% NS 120ML, ionotrop, Rx Only, use with a Curlin or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Lot numbers, UPCs & expiration codes
Beyond Use Date: December 24-31, 2022
Where it was sold
Dispensed to Patients Nationwide.
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-0307-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 27, 2022
- FDA report date
- Feb 22, 2023
- Quantity
- 83 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sentara Infusion Services
Original FDA data
Every field from FDA enforcement report D-0307-2023, exactly as published.
Show all FDA fields
- City
- Chesapeake
- State
- VA
- Status
- Terminated
- Country
- United States
- Event ID
- 91466
- Address
- 535 Independence Pkwy Ste 300
- Code information
- Beyond Use Date: December 24-31, 2022
- Postal code
- 23320-5176
- Report date
- Feb 22, 2023
- Product type
- Drugs
- Recall number
- D-0307-2023
- Classification
- Class II
- Recalling firm
- Sentara Infusion Services
- Product quantity
- 83 bags
- Termination date
- Feb 20, 2026
- Reason for recall
- Lack of sterility assurance
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Milrinone (a) 104MG IN 0.45% NS 130ML,(b) 108MG IN 0.45% NS 135ML, (c) 120MG IN 0.45% NS 150ML, (d) 136MG IN 0.45% NS 170ML, (e) 144MG IN 0.45% NS 180ML, (f) 160MG IN 0.45% NS 200ML, (g) 168MG IN 0.45% NS 210ML, (h) 192MG IN 0.45% NS 240ML, (i) 44MG IN 0.45% NS 55 ML, (j) 52MG IN 0.45% NS 65ML, (k) 56MG IN 0.45% NS 70ML, (l) 68MG IN 0.45% NS 85ML, (m) 84MG IN 0.45% NS 105ML, (n) 88MG IN 0.45% NS 110ML, (o) 92MG IN 0.45% NS 115ML, (p) 96MG IN 0.45% NS 120ML, ionotrop, Rx Only, use with a Curlin or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Distribution pattern
- Dispensed to Patients Nationwide.
- Recall initiation date
- Dec 27, 2022
- Initial firm notification
- Telephone
- Center classification date
- Feb 15, 2023