ChemLifeIntel
Access
FACILITY INTELLIGENCE

ProRx — Exton

Operated by ProRx LLC · Exton, PA
FormulationLast inspection: —
FDA FEI number
Formulation
Manufacturing type
Last inspection outcome
3
Intelligence briefs

Regulatory Observation Log

REGULATORY INTELLIGENCERecall2025-11-05

ProRx LLC Initiates Class II Recall of Semaglutide Injection Due to Sterility Concerns, Marking Second Such Event

ProRx LLC has initiated a Class II recall of 2,649 vials of Semaglutide Injection (2.5mg/1mL) due to a lack of sterility assurance. This marks the second sterility-related recall for ProRx LLC in just over a year, raising significant concerns for procurement and regulatory teams regarding supply chain reliability and patient safety from compounded products.

MK
Meera Krishnan
Senior Regulatory Intelligence Analyst
Trending signal
REGULATORY INTELLIGENCERecall2025-11-05

ProRx LLC Faces Second Sterility Recall for Compounded Semaglutide Injection, Raising Supply Chain Risks

ProRx LLC has initiated a Class II recall of 8,310 vials of Semaglutide Injection due to a lack of sterility assurance, impacting distribution in Texas and Utah. This marks the second sterility-related recall for ProRx LLC's compounded injectables within a year, following a Tirzepatide recall in 2024. Procurement and regulatory teams must immediately assess supply chain exposure and re-evaluate ProRx LLC's reliability as a sterile drug manufacturer.

RM
Rohan Mehta
Senior Supply Chain Intelligence Analyst
Trending signal
REGULATORY INTELLIGENCERecall2024-09-11

FDA Mandates Nationwide Recall of ProRx LLC's Compounded Tirzepatide Due to Sterility Concerns

ProRx LLC has initiated a nationwide Class II recall of 37 vials of compounded Tirzepatide injection from its Exton, PA facility, citing a lack of assurance of sterility. This event underscores critical quality control vulnerabilities in sterile compounding, necessitating immediate review of supplier qualification processes and robust quality assurance protocols for procurement and regulatory teams.

PS
Priya Subramaniam
Intelligence Analyst