FDA recall D-0619-2016

Product

POTASSIUM CHLORIDE in D 5 1/2NS, Packaged in a) 40 mEq KCL/LITER 1000ML Homepumps and b) 160 mEq KCL/LITER 500ML 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-0619-2016