Bimix #3 in Vial recalled over sterility concerns

Recall date

September 12, 2019

Source

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

Official notice title

KRS Global Biotechnology, Inc recalls Bimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate 3 mg/mL) in 5 mL Vial, Rx Only, KRS Global Biotechnology 791 Pa…

Recall number

D-0043-2020

FDA classification

Class II

Brand / firm

KRS Global Biotechnology, Inc

Sold / distributed

Nationwide

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

Bimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate 3 mg/mL) in 5 mL Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676500