HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0 recalled over sterility concerns

Recall date

October 19, 2017

Source

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

Official notice title

SCA Pharmaceuticals, LLC recalls HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50 mL (HYDROmorphone Total Dose 1000 mcg)…

Recall number

D-0061-2018

FDA classification

Class II

Brand / firm

SCA Pharmaceuticals, LLC

Sold / distributed

Nationwide in the United States

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

HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50 mL (HYDROmorphone Total Dose 1000 mcg) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0331-22