Milrinone in 0 recalled over sterility concerns

Recall date

September 18, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Sentara Enterprises recalls Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in 100ML Homepumps, c) 92MG in 115ML Homepumps, d…

Recall number

D-0616-2016

FDA classification

Class II

Brand / firm

Sentara Enterprises

Sold / distributed

U.S. Including: VA, NC

Why it was recalled

Lack of Assurance of Sterility: Product sterility cannot be guaranteed.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.