FDA-Drug2025-11-05Class IIPROCESSING DEFECT
Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09
Hazard
Lack of Assurance of Sterility
Intended for
Adults
Illnesses reported
None reported
Sold states
TX and UT
Affected count
11,119 vials
Manufactured in
619 Jeffers Cir, N/A, Exton, PA, United States
Products
Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0117-2026Want us to check the next one for you?
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