D-0511-2024 Class I Ongoing
FDA drug recall D-0511-2024 was initiated by Revive Rx LLC Dba Revive Rx Pharmacy on Apr 20, 2024 and is designated Class I. Reason for recall: Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate The recall status is ongoing. Affected quantity: 751 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 5, 2024
- Initiation Date
- Apr 20, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 751 vials
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
Reason for Recall
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Distribution Pattern
USA Nationwide
Code Information
Lot #: 748127, Exp 9/24/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0511-2024
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026