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.
Reason for recall: Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Recall initiated: 20150918
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated