Quality & complianceOfficial

FDA classifies Carolina Infusion Tri-Mix compounded drug recall as Class II over sterility assurance

🇺🇸 FDA enforcement report · Wed 14 Oct 2026

Carolina Infusion's Tri-MIX (PAPAV/PHENTO/ALPROS) is under an ongoing nationwide US recall, with FDA citing a lack of assurance of sterility.

The US Food and Drug Administration has listed a Class II recall of Tri-MIX (PAPAV/PHENTO/ALPROS), a compounded product from Carolina Infusion, LLC. The entry appears in the agency's enforcement report under recall number D-0031-2027.

FDA gives the reason as lack of assurance of sterility. Two causes are cited: the formulation used bacteriostatic water, and the processing equipment used for the compounded product was also implicated.

The recall is recorded as ongoing, and the product was distributed nationwide within the US. The text available for this item does not give lot numbers, quantities, recall initiation dates or the product's strength and presentation, so the scale of the action cannot be assessed from it.

By way of context, FDA uses Class II for recalls where use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote.

What it means for your team

  • Compounding and outsourcing quality teams should note that both the diluent choice (bacteriostatic water) and processing equipment were cited as sterility-assurance concerns.
  • Pharmacies, clinics and distributors that handled Tri-MIX from Carolina Infusion should check the full FDA enforcement report entry for lot and code details, as these are not in the summary.
  • Pharmacovigilance teams may wish to watch for any adverse event reports linked to the product, given the sterility concerns and the ongoing recall status.

Official source: FDA enforcement report ↗

Article written by VigiEye from the official source (FDA enforcement report). AI-assisted; check the source before acting.

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