SEMAGLUTIDE 10mg/ recalled over sterility concerns

Recall date

August 22, 2024

Source

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

Official notice title

ProRx LLC recalls SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 8…

Recall number

D-0653-2024

FDA classification

Class II

Brand / firm

ProRx LLC

Sold / distributed

Nationwide in the USA

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

SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04