FDA Drug Moderate Class II Terminated

CEFAZOLIN, Packaged as a) 625MG in 6.2ML Syringes, b) 2GM in 20ML Syringes, c) 1GM in 50ML Homepumps, d) 2GM in 100ML Homepumps, and e) 12GM in 600ML 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-0615-2016

Product Description

Reason for Recall

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

Details

Recalling Firm: Sentara Enterprises
Units Affected: a) 4 Syringes, b) 49 Syringes, c) 18 Bags, d) 80 Bags, e) 23 Bags
Distribution: U.S. Including: VA, NC
Location: Chesapeake, VA

Frequently Asked Questions

What product was recalled? ▼

CEFAZOLIN, Packaged as a) 625MG in 6.2ML Syringes, b) 2GM in 20ML Syringes, c) 1GM in 50ML Homepumps, d) 2GM in 100ML Homepumps, and e) 12GM in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.. Recalled by Sentara Enterprises. Units affected: a) 4 Syringes, b) 49 Syringes, c) 18 Bags, d) 80 Bags, e) 23 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-0615-2016.