FDA-Drug2025-11-05Class II

Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-209-03

ProRx LLC
Hazard

Lack of Assurance of Sterility

Sold states
TX and UT
Affected count
2,761 vials
Manufactured in
619 Jeffers Cir, N/A, Exton, PA, United States
Products
Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-209-03

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0120-2026

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