Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Pr...
FDA Recall #D-0511-2024 — Class I — April 20, 2024
Product Description
Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr A, Houston, TX 77018, internally assigned NDC 99000-9278-64
Reason for Recall
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Recalling Firm
Revive Rx LLC dba Revive Rx Pharmacy — Houston, TX
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
751 vials
Distribution
USA Nationwide
Code Information
Lot #: 748127, Exp 9/24/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated