Recalls / Class II

Class IID-0652-2024

Product

SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-01

Affected lot / code info

Lot #: ProRx052424, BUD 11/23/2024 ProRx060724, BUD 12/06/2024 ProRx061124, BUD 12/10/2024 ProRx061924, BUD 12/18/2024

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

8,396 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-0652-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.