Milrinone IV Bag (Sentara) – Sterility Concern (2022)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 o
Brand
Sentara Infusion Services
Lot Codes / Batch Numbers
Beyond Use Date: December 24-31, 2022
Products Sold
Beyond Use Date: December 24-31, 2022
Sentara Infusion Services is recalling Milrinone (a) 104MG IN 0.45% NS 130ML,(b) 108MG IN 0.45% NS 135ML, (c) 120MG IN 0.45% NS 150ML, (d) due to Lack of sterility assurance. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of sterility assurance
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026