FDA recall D-0307-2023

Product

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

Reason for recall

Lack of sterility assurance

Distribution

Dispensed to Patients Nationwide.

Key facts

Status

Terminated

Initiation date

2022-12-27

Report date

2023-02-22

Termination date

2026-02-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chesapeake, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0307-2023