FDA recall D-0511-2024

Revive Rx LLC dba Revive Rx Pharmacy · Class I · drug

Product

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

Distribution

USA Nationwide

Key facts

Status: Ongoing
Initiation date: 2024-04-20
Report date: 2024-06-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0511-2024