Oxytocin 30 USP Units Added to 0 recalled over sterility concerns

Recall date

November 18, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Cantrell Drug Company recalls Oxytocin 30 USP Units Added to 0.9% Sodium Chloride, 500 mL Bag, Single-Dose Bag, Injection Solution for IV Use Only, R…

Recall number

D-0201-2017

FDA classification

Class II

Brand / firm

Cantrell Drug Company

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

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

What was recalled

Oxytocin 30 USP Units Added to 0.9% Sodium Chloride, 500 mL Bag, Single-Dose Bag, Injection Solution for IV Use Only, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-056-30