Drug & medication recalls Moderate risk

HEPARIN 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 HEPARIN 1,000 Units in NS 250mL. (Heparin Sodium, USP 1,000 Units, 0.9% Sodium Chloride, USP 250 mL) Volume: 251 mL. Si…
Recall number
D-0948-2018
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

HEPARIN 1,000 Units in NS 250mL. (Heparin Sodium, USP 1,000 Units, 0.9% Sodium Chloride, USP 250 mL) Volume: 251 mL. Single dose bag. For: Adventist Medical Center Hanford. By: Avella of Huston, 9265 Kirby Dr., Houston TX, 77054. NDC 42852-747-25

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