D-0653-2024 Class II Ongoing
FDA drug recall D-0653-2024 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: 1,960 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
- 1,960 vials
Product Description
SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide in the USA
Code Information
ProRx061424, BUD 12/13/2024