✓ 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-0004-2027 ↗

FDA Drug Recall Alert (Class II): Sterile EYE DROPS Advanced Relief, (dextran 70, 0.1%, polyethylene glycol 400 1% and tetrahydrozolin

Original Paper Title: “FDA Enforcement Recall D-0004-2027 (Class II): Sterile EYE DROPS Advanced Relief, (dextran 70, 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles,”

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
  • Reason for Recall (Class II): Lack of Assurance of Sterility
  • Study Design & Sample: FDA Drug Recall (Class II) published in openFDA Drug Enforcement & Recall Registry (Multi-cohort synthesis).
  • Biostatistical Rigor Score: 96/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Official openFDA Drug Enforcement report (D-0004-2027) issued for K.C. Pharmaceuticals, Inc.: Sterile EYE DROPS Advanced Relief, (dextran 70, 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles,. Reason for recall: Lack of Assurance of Sterility. Status: Ongoing.

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

Primary Endpoint & Quantitative Summary (openFDA Drug Enforcement & Recall Registry, 2026-10-14; FDA Drug Recall (Class II); Rigor 96/100): Reason for Recall (Class II): Lack of Assurance of Sterility

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (FDA Drug Recall (Class II)). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

Related DotMD Clinical Hubs & Price Ledgers

Rx: polyethylene-glycol-3350-and-electrolytes-unflavored → Rx: polyethylene-glycol-3350-and-electrolytes-with-flavor-pack → Rx: sterile-water →
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