FDAClass IISeptember 11, 2024

Tirzepatide 60 Mg/3ml recall: Sterility Concern

TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02

Why was Tirzepatide 60 Mg/3ml recalled?

Lack of Assurance of Sterility

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# ProRx052224, BUD 11/21/2024 ProRx061024, BUD 12/09/2024

Product
TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02
Recalling firm
ProRx LLC
Quantity
1,732 vials
Distribution
Nationwide in the USA
Recall date
September 11, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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