The Recall Desk
HighFDA (Drugs)·D-0616-2016·Announced 2016-02-03

Sentara Recalls Milrinone Infusions Due to Sterility Concerns

Sentara Enterprises is recalling specific lots of Milrinone in 0.45% NS homepumps because the sterility of the product cannot be guaranteed.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility failure) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

Sentara Enterprises is recalling specific lots of Milrinone in 0.45% NS, packaged in various Homepump sizes. The recall is being conducted because the company cannot guarantee the sterility of the affected product.

The affected lots were compounded between September 11, 2015, and September 17, 2015. The product was distributed in Virginia and North Carolina. The recall involves 15 different package sizes, ranging from 52mg in 65ml to 200mg in 250ml.

Patients who have received these specific lots should contact their healthcare provider for guidance. The recall is classified as FDA Class II, indicating that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product
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 130ML Homepumps, e) 112MG in 140ML Homepumps, f) 120MG in 150ML Homepumps, g) 124MG in 155ML Homepumps, h) 128MG in 160ML, i) 136MG in 170ML Homepumps
Manufacturer
Sentara Enterprises
Category
Drug — Injectable
Hazard

Is your product affected?

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

Lot numbers (17)

  • All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 1-Oct-15
  • b) 29-Sep-15
  • c) 25-Sep-15
  • 30-Sep-15
  • d) 25-Sep-15
  • e) 1-Oct-15
  • f) 29-Sep-15
  • g) 26-Sep-15
  • h) 1-Oct-15
  • i) 29-Sep-15
  • j) 25-Sep-15
  • k) 1-Oct-15
  • l) 25-Sep-15
  • m) 27-Sep-15
  • 1-Oct-15
  • n) 24-Sep-15
  • o) 25-Sep-15

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 34 recalled by Sentara Enterprises under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 34 products in this recall →

Related recalls

Same manufacturer · Sentara Enterprises

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Same hazard · sterility failure

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