Drug & medication recalls Moderate risk

PHENYLephrine 20 mg 20 mg recalled over sterility concerns

Recall date
June 12, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Avella of Deer Valley, Inc. Store 38 recalls PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL) Volume: 252 mL. Single dose bag. For: Vid…
Recall number
D-0962-2018
FDA classification
Class II
Brand / firm
Avella of Deer Valley, Inc. Store 38
Sold / distributed
Nationwide in the USA

Why it was recalled

Lack of Assurance of Sterility: Potential leakage of bags.

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

What was recalled

PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL) Volume: 252 mL. Single dose bag. For: Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-894-25

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