ProRx Semaglutide Injection Recall Due to Lack of Sterility Assurance
ProRx has recalled 2,649 vials of Semaglutide Injection distributed in Texas and Utah due to lack of assurance of sterility. Patients using affected vials may face infection risks.
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 lack of sterility assurance on an injectable medication. No illnesses or injuries have been reported. This meets the rubric criterion for High severity: a risk-of-harm drug product where injury has not yet been reported.
Plain-English summary
ProRx LLC is recalling 2,649 vials of Semaglutide Injection, 2.5mg/1mL (NDC 84139-225-06), lot Prorx051525-5, due to a lack of assurance of sterility. The recalled vials were distributed in Texas and Utah.
Injectable medications depend on sterility to ensure patient safety. When sterility assurance cannot be confirmed, patients who use the product face potential risks of infection and other health consequences. The specific cause of this recall is not detailed in the notice.
Patients who currently have vials from lot Prorx051525-5 should consult their healthcare provider immediately. Do not use vials from this lot. Individuals with questions about whether they have received affected product should check with their pharmacy or healthcare provider.
The recalled product
- Product
- Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-06
- Manufacturer
- ProRx LLC
- Category
- Drug — Injectable Medication
- Hazard
- sterility-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 (1)
- Lot Prorx051525-5
Distribution
Distributed in 2 states:
- TX
- UT
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