FDA recall D-0626-2016

Sentara Enterprises · Class II · drug

Product

GANCICLOVIR in NS, Packaged as a) 320MG in 64ML Homepumps and b) 2440MG in 488ML 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.

Distribution

U.S. Including: VA, NC

Key facts

Status: Terminated
Initiation date: 2015-09-18
Report date: 2016-02-03
Termination date: 2016-06-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Chesapeake, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0626-2016