Sermorelin Acetate 3 mg / 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 Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Bo…

Recall number

D-0098-2020

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

Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321601122