AZACTAM 2GM in NS recalled over sterility concerns

Recall date

September 18, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Sentara Enterprises recalls AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence P…

Recall number

D-0638-2016

FDA classification

Class II

Brand / firm

Sentara Enterprises

Sold / distributed

U.S. Including: VA, NC

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.