PlainRecalls
FDA Drug Moderate Class II Terminated

FLUCONAZOLE IN NACL 400MG in NS, Packaged in 200ML 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-0633-2016

Product Description

FLUCONAZOLE IN NACL 400MG in NS, Packaged in 200ML 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
7 Bags
Distribution
U.S. Including: VA, NC
Location
Chesapeake, VA

Frequently Asked Questions

What product was recalled?
FLUCONAZOLE IN NACL 400MG in NS, Packaged in 200ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.. Recalled by Sentara Enterprises. Units affected: 7 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-0633-2016.