SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX...
FDA Recall #D-0653-2024 — Class II — August 22, 2024
Product Description
SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04
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
1,960 vials
Distribution
Nationwide in the USA
Code Information
ProRx061424, BUD 12/13/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated