ChemLifeIntel
Access
ChemLifeIntel/Companies/ProRx LLC

ProRx LLC

HIGH RISKHQ: Exton · Private · Founded —
LISTINGPrivateFOUNDED0
FOCUS THERAPY AREAS
Manufacturer
COMPANY INTELLIGENCE SNAPSHOTlive
1
Manufacturing Sites
3
Intelligence Briefs
0
Active Regulatory Actions
US
HQ Country
NO ACTIVE REGULATORY ACTIONSClean compliance footprint across 1 monitored sites · HQ Exton
View regulatory detail

INTELLIGENCE

Showing 3 of 3 briefs on ProRx LLC
REGULATORY INTELLIGENCE·Recall

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.

90-Day Activity
ProRx LLCSemaglutideProRx — Exton · Exton
MKMeera Krishnan· Senior Regulatory Intelligence Analyst
2025-11-05▲ Trending signal
REGULATORY INTELLIGENCE·Recall

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.

90-Day Activity
ProRx LLCSemaglutideProRx — Exton · Exton
RMRohan Mehta· Senior Supply Chain Intelligence Analyst
2025-11-05▲ Trending signal
REGULATORY INTELLIGENCE·Recall

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.

90-Day Activity
ProRx LLCProRx — Exton · Exton
PSPriya Subramaniam· Intelligence Analyst
2024-09-11