SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by...
FDA Recall #D-0652-2024 — Class II — August 22, 2024
Product Description
SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-01
Reason for Recall
Lack of Assurance of Sterility
Recalling Firm
ProRx LLC — Exton, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
8,396 vials
Distribution
Nationwide in the USA
Code Information
Lot #: ProRx052424, BUD 11/23/2024 ProRx060724, BUD 12/06/2024 ProRx061124, BUD 12/10/2024 ProRx061924, BUD 12/18/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated