Drug & medication recalls Moderate risk

Sermorelin Acetate 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/mL/GHRP6, 1.8 mg/mL/GHRP2, 1.8 mg/mL, 3 mL Injections-CART-Item#: 73752, For SC Use, Rx Only,…
Recall number
D-0094-2020
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/mL/GHRP6, 1.8 mg/mL/GHRP2, 1.8 mg/mL, 3 mL Injections-CART-Item#: 73752, For SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.

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