Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Recalling firm

Caplin Steriles Limited

NDC code

72485-502-01

Origin

N/A, India

Initiated by

Voluntary: Firm initiated

FDA recall number

D-1144-2023

Other Milrinone recalls

See all

Class II · Moderate risk Terminated Dec 27, 2022

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

Sentara Infusion Services D-0307-2023

Class II · Moderate risk Terminated Jul 9, 2019

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.

Pfizer Inc. NDC 0409-2776-23 D-1487-2019

Class II · Moderate risk Terminated Jul 9, 2019

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.

Pfizer Inc. NDC 0409-2776-02 D-1486-2019

Class II · Moderate risk Terminated May 15, 2017

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.

Baxter Healthcare Corporation NDC 0338-6010-48 D-0789-2017

Class II · Moderate risk Terminated Apr 18, 2016

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

Baptist Health Medical Towers Pharmacy and Infusion Services D-0930-2016