PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: February 3, 2016 Initiated: September 18, 2015 #D-0619-2016

Product Description

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.

Details

Recalling Firm
Sentara Enterprises
Units Affected
a) 7 Bags, b) 2 Bags
Distribution
U.S. Including: VA, NC
Location
Chesapeake, VA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Sentara Enterprises. Units affected: a) 7 Bags, b) 2 Bags.
Why was this product recalled?
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 3, 2016. Severity: Moderate. Recall number: D-0619-2016.