PlainRecalls
FDA Drug Moderate Class II Ongoing

SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04

Reported: September 11, 2024 Initiated: August 22, 2024 #D-0653-2024

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

Details

Recalling Firm
ProRx LLC
Units Affected
1,960 vials
Distribution
Nationwide in the USA
Location
Exton, PA

Frequently Asked Questions

What product was recalled?
SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04. Recalled by ProRx LLC. Units affected: 1,960 vials.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on September 11, 2024. Severity: Moderate. Recall number: D-0653-2024.