PlainRecalls
FDA Drug Moderate Class II Terminated

GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, and c) 375MG in a 75ML 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-0641-2016

Product Description

GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, and c) 375MG in a 75ML 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) 11 bags, b) 9 Bags, c) 3 Bags
Distribution
U.S. Including: VA, NC
Location
Chesapeake, VA

Frequently Asked Questions

What product was recalled?
GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, and c) 375MG in a 75ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.. Recalled by Sentara Enterprises. Units affected: a) 11 bags, b) 9 Bags, c) 3 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-0641-2016.