Rocuronium Br 50 mg/ recalled over sterility concerns

Recall date

December 17, 2020

Source

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

Official notice title

SCA Pharmaceuticals recalls Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(barcode 7000485009) Rx Only, SCA Pharmaceutic…

Recall number

D-0211-2021

FDA classification

Class II

Brand / firm

SCA Pharmaceuticals

Sold / distributed

Product was distributed to hospitals nationwide.

Why it was recalled

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

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 Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(barcode 7000485009) Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 and b) 5 mL Single Dose Syringe White Label (barcode 70004085028), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205