FDA Recall D-0511-2024

Revive Rx LLC dba Revive Rx Pharmacy · Houston, TX

Class I — life-threatening Ongoing 754 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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

Lot / code: Lot #: 748127, Exp 9/24/2024

Quantity: 751 vials

Reason for recall

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

Recall record

Recall number: D-0511-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Telephone
Distribution: USA Nationwide
Recall initiated: 2024-04-20
Classified by FDA Center: 2024-05-29
FDA published: 2024-06-05
Recalling firm: Revive Rx LLC dba Revive Rx Pharmacy
Firm location: Houston, TX

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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