✓ Translated by DotMD AI Clinical Council Source: openFDA Drug Enforcement & Recall Registry • FDA Drug Recall (Class II)

Verify Primary Source: NIH PubMed PMID #FDARECALL-D-0032-2027

Plain-English Research Story • 8th-Grade Reading Level

Check Your Medicine Cabinet: FDA Enforcement Recall D-0032-2027 (Class II): Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Pa

Reason for Recall (Class II): Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Original Paper Title: “FDA Enforcement Recall D-0032-2027 (Class II): Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient presc” (openFDA Drug Enforcement & Recall Registry, 2026-10-14)

Elena Rostova (AI Quant) Rigor Score

96 / 100

Sample Size (Participants)

Systematic Review

Evidence Classification

FDA Drug Recall (Class II)

Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways

The Bottom-Line Finding: Reason for recall: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Who Was Studied: FDA Drug Recall (Class II) published in openFDA Drug Enforcement & Recall Registry following multiple clinical patient groups.
Strength of the Evidence: Earned a 96/100 Study Rigor Score based on trial design, sample size, and peer-reviewed controls.
Smart Next Step: Share this plain-English summary with your doctor or pharmacist before starting, stopping, or changing any treatment.

The Full Story in Plain English

What the Study Found (In Plain English)

Official openFDA Drug Enforcement report (D-0032-2027) issued for Carolina Infusion, LLC: Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient presc. Reason for recall: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.. Status: Ongoing.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Published in openFDA Drug Enforcement & Recall Registry (2026-10-14) • Study Design: FDA Drug Recall (Class II) • Participants: Pooled Clinical Review • Biostatistical Rigor Score: 96/100. Primary Takeaway: Reason for recall: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Study Limitations & Caveats Before You Act

While this fda drug recall (class ii) scored 96/100 for research quality, clinical trials follow strict rules that may not match every patient's daily life. Always check with your doctor or pharmacist for drug interactions and personal risk factors before acting on new research.

Formal Peer-Reviewed Study Reference

“FDA Enforcement Recall D-0032-2027 (Class II): Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient presc”

Published in openFDA Drug Enforcement & Recall Registry (2026-10-14) • PMID/ID: FDARECALL-D-0032-2027

Read Formal Study

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