TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 1934...
FDA Recall #D-0656-2024 — Class II — August 22, 2024
Product Description
TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02
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
1,732 vials
Distribution
Nationwide in the USA
Code Information
Lot# ProRx052224, BUD 11/21/2024 ProRx061024, BUD 12/09/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated