ProRx Compounded Semaglutide/Cyanocobalamin Injection Recalled Due to Sterility Assurance Issues
ProRx LLC is recalling 500 vials of compounded Semaglutide/Cyanocobalamin Injection (Lot #ProRx031924-1) distributed nationwide in the United States due to lack of sterility assurance. The beyond-use date is 09/18/2024.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a compounded injectable medication due to inability to assure sterility standards. This represents a risk-of-harm product where no illnesses have been reported, meeting the criterion for High severity.
Plain-English summary
ProRx LLC is recalling one lot of compounded Semaglutide/Cyanocobalamin Injection (2.5/0.5 mg/mL, 2 mL multiple-dose vials) distributed nationwide in the United States. The recalled product is Lot #ProRx031924-1 with NDC 84139-225-02 and beyond-use date of 09/18/2024, affecting 500 vials.
The recall is issued because the manufacturer cannot assure that the compounded product meets sterility standards.
Patients and healthcare providers who have this medication should contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX 267-565-7008, NDC 84139-225-02
- Manufacturer
- ProRx LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 500
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 (2)
- Lot # ProRx031924-1
- BUD 09/18/2024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by ProRx LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
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