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D-0654-2024Class II

ProRx LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
ProRx LLC
Product type
Drug
Status
Ongoing
Report date
2024-09-11
Distribution
Nationwide in the USA
Firm state
PA
Product quantity
500 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility

Product description

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

Code / lot info

Lot # ProRx031924-1, BUD 09/18/2024

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →