D-0511-2024Class I

Revive Rx LLC dba Revive Rx Pharmacy

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2024-06-05

Distribution

USA Nationwide

Firm state

Product quantity

751 vials

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Documentation & Change Control

Reason for recall

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

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

Code / lot info

Lot #: 748127, Exp 9/24/2024

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See all Documentation & Change Control recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.