GENTAMICIN recalled over sterility concerns

Recall date

September 18, 2015

Source

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

Official notice title

Sentara Enterprises recalls GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, and c) 375MG in a 75ML Homepumps, Rx Only…

Recall number

D-0641-2016

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

GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, and c) 375MG in a 75ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.