FDA recall D-0651-2024

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

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2024-08-22

Report date

2024-09-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Exton, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0651-2024