Revive Rx LLC dba Revive Rx Pharmacy recalls Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Ph…

Recall date

April 20, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0511-2024

FDA classification

Class I

Brand / firm

Revive Rx LLC dba Revive Rx Pharmacy

Sold / distributed

USA Nationwide

Why it was recalled

Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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