D-0650-2024 Class II Ongoing

Recalled by ProRx LLC — Exton, PA

FDA drug recall D-0650-2024 was initiated by ProRx LLC on August 22, 2024 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 2,490 vials.

Recall Details

Product Type
Drugs
Report Date
September 11, 2024
Initiation Date
August 22, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,490 vials

Product Description

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

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide in the USA

Code Information

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