Recalls / Class II

Class IID-0650-2024

Product

Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-01

Affected lot / code info

Lot #: ProRx031924, BUD 09/18/2024 ProRx032624, BUD 09/25/2024 ProRx041324, BUD 10/12/2024

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm

ProRx LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

619 Jeffers Cir, Exton, Pennsylvania 19341-2540

Distribution

Quantity

2,490 vials

Distribution pattern

Nationwide in the USA

Timeline

Recall initiated

2024-08-22

FDA classified

2024-09-05

Posted by FDA

2024-09-11

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0650-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.