FDA recall D-0613-2016

Product

SOD CHLORIDE (Sodium Chloride), Packaged in a) 0.9% in 30ML Homepumps, b) 0.9% 218ML Homepumps, c) 0.45% in 500ML Homepumps, d) 0.9% in 500ML Homepumps, e) 0.9% in 1500ML Homepumps, f) 0.45% in 1920ML 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-0613-2016