TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 1934...
FDA Recall #D-0655-2024 — Class II — August 22, 2024
Product Description
TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01
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
1,489 vials
Distribution
Nationwide in the USA
Code Information
Lot # ProRx051424, BUD 11/13/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated