Tirzepatide and 20 mg/mL 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 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008,…

Recall number

D-0651-2024

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 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, NDC 84139-210-01