FDA recalls Milrinone injectable medication due to lack of sterility assurance

Plain-English summary

Sentara Infusion Services is recalling multiple formulations of Milrinone injectable medication due to lack of sterility assurance. The affected products consist of 83 bags in various strengths ranging from 44 mg to 192 mg, formulated in 0.45% sodium chloride solution. These products were dispensed to patients nationwide with Beyond Use Dates of December 24-31, 2022.

The recall was initiated due to deficiencies in sterility assurance processes. While no illnesses or injuries have been reported to date, failure of sterility assurance in injectable medications poses a potential health risk.

Patients who received Milrinone from Sentara Infusion Services should contact their healthcare provider immediately. Healthcare providers should verify whether affected medication was dispensed to their patients and take appropriate action regarding patient care and medication disposal.

The recalled product

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

Manufacturer

Sentara Infusion Services

Category

Drug — Injectable Medication

Hazard

• sterility-assurance
• contamination-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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