Tirzepatide Injectable Drug Recalled for Sterility Assurance Defect
ProRx LLC is recalling 1,732 vials of Tirzepatide 60 mg/3mL nationwide due to lack of assurance of sterility. Affected lots have beyond-use dates of 11/21/2024 and 12/09/2024.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a sterility defect in an injectable drug. No illnesses or injuries have been reported. The lack of sterility assurance in injectable medications represents a significant risk-of-harm to patients, meeting the criteria for High severity.
Plain-English summary
ProRx LLC is recalling 1,732 vials of Tirzepatide 60 mg/3mL (20 mg/mL), a prescription injectable medication, due to lack of assurance of sterility. The recalled product is a 3-milliliter multiple-dose vial manufactured by ProRx in Exton, Pennsylvania (NDC 84139-210-02).
The affected lots are: ProRx052224 (beyond-use date November 21, 2024) and ProRx061024 (beyond-use date December 9, 2024). This recall applies nationwide in the United States.
Healthcare providers and patients who have received doses from these lots should stop using the product immediately and consult with their healthcare provider about alternative treatment options. The lack of sterility assurance in injectable medications poses a risk of serious infection. Patients should return any remaining product to their pharmacy or contact the manufacturer for instructions on how to return the recalled vials.
This is a Class II recall as determined by the Food and Drug Administration.
The recalled product
- Product
- TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02
- Manufacturer
- ProRx LLC
- Category
- Drug — Injectable Medication
- Hazard
- sterility-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot# ProRx052224
- BUD 11/21/2024 ProRx061024
- BUD 12/09/2024
Distribution
Distributed nationwide across the United States.
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