FDAClass IJune 5, 2024

Tirzepatide 10 mg/0.5 mL Sterile Solution recall: Labeling Error

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…

Why was Tirzepatide 10 mg/0.5 mL Sterile Solution recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 748127, Exp 9/24/2024

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…
Recalling firm
Revive Rx LLC dba Revive Rx Pharmacy
Quantity
751 vials
Distribution
USA Nationwide
Recall date
June 5, 2024
Classification
Class I
Status
Ongoing
Agency
FDA (drug)
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