Sodium Citrate 40 mg/mL / Gentamicin 0 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 Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. 30 mL vial for Intra-Catheter Use Only, Rx Only, KRS Global Biote…

Recall number

D-0102-2020

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

Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. 30 mL vial for Intra-Catheter Use Only, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676603