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Recall Observatory FDA recall evidence

Drug product

Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-06

D-0118-2026

October 15, 2025

Class II

Product summary

Firm
ProRx LLC
Event
Event 97808
Status
Ongoing
Classification
Class II
Quantity
2,649 vials
Official record key
drug-enforcement:D-0118-2026

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot Prorx051525-5

Distribution pattern: TX and UT

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility