Drug FDA Class I Ongoing Mislabeling
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
Revive Rx LLC dba Revive Rx Pharmacy Published Jun 5, 2024
Risk level
Class IDangerous or defective — could cause serious health problems or death.
Severity score 85/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Revive Rx LLC dba Revive Rx Pharmacy or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Affected products (1)
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
751 vials
Code info: Lot #: 748127, Exp 9/24/2024
Affected areas
Nationwide
Timeline
- InitiatedApr 20, 2024
- PublishedJun 5, 2024
- Recall number
- D-0511-2024
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.