FDA recall D-0653-2024

Product

SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04

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-0653-2024