Drug & medication recalls Moderate risk

PENICILLIN in D5W recalled over sterility concerns

Recall date
September 18, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Sentara Enterprises recalls PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML Homepumps, Rx Only. SENTARA HOME HEALTH S…
Recall number
D-0632-2016
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

PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

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