Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL recall — Class II (D-0651-2024) · pharmaranks
Class IIOngoing
Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL recall
FDA recall D-0651-2024 · initiated Aug 22, 2024
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility
Details
Product
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
Recalling company
ProRx LLC
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
Nationwide in the USA
Initiated
Aug 22, 2024
FDA report date
Sep 11, 2024
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.