US Drug Recall Register
Class II · Moderate risk Terminated Initiated Sep 18, 2015 (11 years ago)

VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML Homepumps, c)…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML Homepumps, c) 850MG in 170ML Homepumps, d) 1GM in 200ML Homepumps, e) 1.25GM in 250ML Homepumps, f) 1.5GM in 300ML Homepumps, g) 1.75GM in 350ML Homepumps, h) 2GM in 400ML Homepumps, i) 4000MG in 800ML Homepumps, j) 5000MG in 1000ML Homepumps, k) 6GM in 1200ML Homepumps, l) 7.5GM in 1500ML Homepumps, and m) 9000MG in 1800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

Recalling firm
Sentara Enterprises
Origin
VA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0623-2016

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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