Compounded Semaglutide Injection Vials Recalled for Sterility Concerns
ProRx LLC is recalling approximately 8,396 vials of compounded semaglutide due to lack of assurance of sterility. The medication was distributed nationwide.
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 of injectable compounded medication with lack of sterility assurance represents a risk-of-harm product where injury has not yet been reported. Potential for serious infection from contaminated injectables warrants preventative action.
Plain-English summary
ProRx LLC is recalling approximately 8,396 vials of compounded semaglutide 5mg/2mL (2.5mg/mL) due to lack of assurance of sterility. The recall affects vials manufactured at ProRx facilities in Exton, Pennsylvania.
The affected medication was distributed nationwide in the United States. Affected lots include ProRx052424 (BUD 11/23/2024), ProRx060724 (BUD 12/06/2024), ProRx061124 (BUD 12/10/2024), and ProRx061924 (BUD 12/18/2024).
Consumers and healthcare providers who have received this compounded semaglutide should not use the affected vials. Patients should consult with their prescribing healthcare provider regarding their medication and explore alternative options. Semaglutide is used for diabetes and weight management; any changes to therapy should be discussed with a healthcare provider.
The recalled product
- Product
- SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-01
- Manufacturer
- ProRx LLC
- Category
- Drug — Compounded Injection
- Hazard
- sterility
- contamination
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 (5)
- Lot #: ProRx052424
- BUD 11/23/2024 ProRx060724
- BUD 12/06/2024 ProRx061124
- BUD 12/10/2024 ProRx061924
- BUD 12/18/2024
Distribution
Distributed nationwide across the United States.
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