⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

ProRx LLC: 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 19

DrugsSource: FDA (drug) · Date: 2025-11-05

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
ProRx LLC
Product
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
Reason / hazard
Lack of Assurance of Sterility
Classification
Class II
Status
Ongoing
Distribution / sold at
TX and UT
Recall initiated
2025-10-15
Code info
Lot PRORX08062025-3
Product quantity
2,761 vials
Voluntary mandated
Voluntary: Firm initiated
City
Exton
State
PA
Country
United States
Event id
97808
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