Drug & medication recalls Moderate risk

Gentamicin 14 recalled over sterility concerns

Recall date
November 10, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Walgreens Infusion Services recalls Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe, Rx Only, Compounded by Option Care 148, San Antonio, T…
Recall number
D-0549-2016
FDA classification
Class II
Brand / firm
Walgreens Infusion Services
Sold / distributed
Texas

Why it was recalled

Lack of Assurance of Sterility

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

What was recalled

Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

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