Drug Enforcement D-0511-2024

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

Status

Ongoing

Classification

Class I

Report Date

June 5, 2024

Termination Date

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Product Information

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
Product quantity
751 vials
Reason for recall
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Recall initiation reason
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Initial firm notification
Telephone
Distribution pattern
USA Nationwide

Location & Firm

Recalling firm
Revive Rx LLC dba Revive Rx Pharmacy
Address
3831 Golf Dr Ste A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0511-2024
Event ID
94550
Recall initiation date
April 20, 2024
Center classification date
May 29, 2024
Code info
Lot #: 748127, Exp 9/24/2024
More code info
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