FDA-Drug2016-02-03Class II

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.

Sentara Enterprises
Hazard

Lack of Assurance of Sterility: Product sterility cannot be guaranteed.

Sold states
U.S. Including: VA, NC
Affected count
a) 2 Bags, b) 1 Bags, c) 2 Bags, d) 4 Bags, e) 7 Bags f) 3 Bags
Manufactured in
535 Independence Pkwy Ste 300, N/A, Chesapeake, VA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0613-2016

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