Drug & medication recalls Moderate risk

Vancomycin 1 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 Vancomycin 1.25gm in D5W 250 mL. ( Vancomycin HCL (USP) 1.25 gm, 5% Dextrose Inj. (USP) 250 mL) Volume: 262 mL. Single…
Recall number
D-0941-2018
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

Vancomycin 1.25gm in D5W 250 mL. ( Vancomycin HCL (USP) 1.25 gm, 5% Dextrose Inj. (USP) 250 mL) Volume: 262 mL. Single dose bag. Avella Specialty Pharmacy, 24416N 19th Avenue, Phoenix, AZ 85085. NDC 42852-617-25

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