Compounded semaglutide injection recalled due to sterility concerns
ProRx LLC is recalling compounded semaglutide injections due to lack of assurance of sterility. The recall affects 2,490 vials 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 pharmaceutical recall for a sterility assurance defect in an injectable product. No illnesses or deaths have been reported. The recall meets the 'risk-of-harm' criterion, as injectable medications with compromised sterility present serious potential for infection, but injury has not yet occurred.
Plain-English summary
ProRx LLC is recalling its compounded semaglutide 2 mL multidose injection (concentration 2.5 mg/mL) due to lack of assurance of sterility. The product is supplied in glass vials under NDC 84139-225-01. A total of 2,490 vials have been distributed nationwide in the United States.
The affected lots are: ProRx031924 (beyond-use date 09/18/2024), ProRx032624 (beyond-use date 09/25/2024), and ProRx041324 (beyond-use date 10/12/2024). Semaglutide is an injectable medication used in treating Type 2 diabetes and obesity.
Compounded injectable medications must meet strict sterility requirements to prevent serious infection and other complications. The recall was issued because the manufacturer cannot provide adequate assurance that the sterility of the recalled vials is maintained.
Patients who have received this product should not use vials from the affected lots and should consult their healthcare provider about their treatment options.
The recalled product
- Product
- Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-01
- Manufacturer
- ProRx LLC
- Category
- Drug — Compounded Injectable
- Hazard
- contamination
- infection-risk
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 (4)
- Lot #: ProRx031924
- BUD 09/18/2024 ProRx032624
- BUD 09/25/2024 ProRx041324
- BUD 10/12/2024
Distribution
Distributed nationwide across the United States.
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