Milrinone NS Homepumps (Sentara) – Sterility Uncertainty (2015)
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 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, j) 144MG in 180ML Homepumps, k) 152MG in 190ML Homepumps, l) 160MG in 200ML Homepumps, m) 172MG in 215ML Homepumps, n) 176MG in 220ML Homepumps, and o) 200MG in 250ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX,
Brand
Sentara Enterprises
Lot Codes / Batch Numbers
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, 30-Sep-15, o) 25-Sep-15
Products Sold
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, 30-Sep-15, o) 25-Sep-15
Sentara Enterprises is recalling Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in 100ML Homepumps, c) 92MG in due to Lack of Assurance of Sterility: Product sterility cannot be guaranteed.. 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 Assurance of Sterility: Product sterility cannot be guaranteed.
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 noticeDistribution
As reported by FDA
NC, VA
Page updated: Jan 7, 2026