FDA recall D-0650-2024

ProRx LLC · Class II · drug

Product

Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-01

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-0650-2024