PlainRecalls
FDA Drug Critical Class I Ongoing

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

Reported: June 5, 2024 Initiated: April 20, 2024 #D-0511-2024

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

Details

Units Affected
751 vials
Distribution
USA Nationwide
Location
Houston, TX

Frequently Asked Questions

What product was recalled?
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. Recalled by Revive Rx LLC dba Revive Rx Pharmacy. Units affected: 751 vials.
Why was this product recalled?
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Which agency issued this recall?
This recall was issued by the FDA Drug on June 5, 2024. Severity: Critical. Recall number: D-0511-2024.