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Recall Observatory FDA recall evidence

Drug product

Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX 267-565-7008, NDC 84139-225-02

D-0654-2024

August 22, 2024

Class II

Product summary

Firm
ProRx LLC
Event
Event 95190
Status
Ongoing
Classification
Class II
Quantity
500 vials
Official record key
drug-enforcement:D-0654-2024

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot # ProRx031924-1, BUD 09/18/2024

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility