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.
Recalled February 3, 2016 · FDA recall D-0641-2016 · Sentara Enterprises
Hazard
Lack of Assurance of Sterility: Product sterility cannot be guaranteed. · FDA Class II
Units
a) 11 bags, b) 9 Bags, c) 3 Bags
Sold at
U.S. Including: VA, NC
Description
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product
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.
Manufacturer(s)
Sentara Enterprises
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →