ChemLifeIntel/Companies/RC Outsourcing, LLC

RC Outsourcing, LLC

HIGH RISKHQ: — · Private · Founded —

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INTELLIGENCE

Showing 2 of 2 briefs on RC Outsourcing, LLC

REGULATORY INTELLIGENCE·Recall

FARMAKEIO OUTSOURCING LLC Initiates Class II Recall for Testosterone/Triamcinolone Pellets Amid Metal Particulate Risk

FARMAKEIO OUTSOURCING LLC initiated a Class II recall (D-0130-2026) for 18,124 Testosterone / Triamcinolone Acetonide sterile pellets due to CGMP deviations and potential metal particulate matter. This nationwide U.S. and Antigua distribution event highlights critical risks in sterile compounding. Procurement and regulatory teams must assess supply chain integrity and reinforce quality assurance protocols to mitigate similar compliance exposures.

90-Day Activity

RC Outsourcing, LLC

CMCatherine Morrow· Senior Regulatory Intelligence Analyst

2025-11-05 Recall

REGULATORY INTELLIGENCE·Recall

FDA Class II Recall: RC Outsourcing's Bevacizumab Syringes Pulled Over Sterility Concerns

RC Outsourcing, LLC initiated a Class II recall for 2,669 Bevacizumab syringes from its Lowellville, OH facility due to sterility assurance concerns. This voluntary action, terminated January 5, 2026, impacts nationwide US distribution. Procurement and regulatory teams must scrutinize compounded sterile product suppliers, reinforcing robust quality oversight to mitigate patient safety risks and supply chain disruptions.

90-Day Activity

RC Outsourcing, LLCBevacizumabHSN 3004.90

MKMeera Krishnan· Senior Regulatory Intelligence Analyst

2025-10-15