TIRZEPATIDE 20 mg/ recalled over sterility concerns

Recall date

August 22, 2024

Source

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

Official notice title

ProRx LLC recalls TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01

Recall number

D-0655-2024

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

TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01