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Recall Observatory FDA recall evidence

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

D-0511-2024

April 20, 2024

Class I

Product summary

Firm
Revive Rx LLC dba Revive Rx Pharmacy
Event
Event 94550
Status
Ongoing
Classification
Class I
Quantity
751 vials
Official record key
drug-enforcement:D-0511-2024

Official wording

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

Code information: Lot #: 748127, Exp 9/24/2024

Distribution pattern: USA Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix-up