Class III · Low risk Terminated
Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC 72485-502-01 (single vial), Rx…
Reason Failed Impurities/Degradation Specifications
Milrinone (a) 104MG IN 0.45% NS 130ML,(b) 108MG IN 0.45% NS 135ML, (c) 120MG IN 0.45% NS…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of sterility assurance
What was recalled
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
- Recalling firm
- Sentara Infusion Services
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0307-2023
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.
Other Milrinone recalls
See all
Class II · Moderate risk Terminated
Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20 mg/100 mL, 100 mL bag, Rx Only, Hospira, Inc., Lake…
Reason Lack of Assurance of Sterility: Bags have the potential to leak.
Class II · Moderate risk Terminated
Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 mg/200 mL, 200 mL bag, Rx Only, Hospira, Inc., Lake…
Reason Lack of Assurance of Sterility: Bags have the potential to leak.
Class II · Moderate risk Terminated
Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare…
Reason Lack of assurance of sterility: customer complaints received for the presence of leaks.
Class II · Moderate risk Terminated
Milrinone 200 mcg/mL in a) D5W-300 mL, b) D5W-400 mL, c) D5W-500 mL and d) D5W-600 mL Bags, FOR IV USE ONLY, Baptist Health…
Reason Lack of Sterility Assurance
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