Drug & medication recalls Moderate risk

Ephedrine Sulfate recalled over sterility concerns

Recall date
January 29, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
US Compounding Inc recalls Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don's Lane Conway, AR 8…
Recall number
D-0508-2019
FDA classification
Class II
Brand / firm
US Compounding Inc
Sold / distributed
U.S.A. Nationwide

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

Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don's Lane Conway, AR 800-718-3588, Barcode: 62295308407

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