ROCuronium Bromide 10 mg per mL 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 ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceutical…

Recall number

D-0068-2018

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

ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-850-09