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
Is Milrinone recalled?
9 FDA recalls mention Milrinone. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Milrinone.
Class II · Moderate risk Terminated
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)…
Reason Lack of sterility assurance
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
Class II · Moderate risk Terminated
Milrinone 0.375 mcg/kg/min D5W bag a) 365 mL, b) 400 mL c) 430 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in 100ML Homepumps, c) 92MG in 115ML Homepumps, d) 104MG in…
Reason Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk Terminated
Milrinone various strengths in dextrose
Reason Lack of sterility assurance.
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