85%Confidence
0Views
FDASource
2026-04-20Date
Summary
Fagron's second vancomycin recall for identical sterility and device issues points to a recurring problem in its compounding process. This may result in increased liability and operational disruptions.
Actionable: Evaluate the long-term viability of Fagron's sterile compounding business segment given repeated quality failures.
AI Confidence: 85%
Data Points
firmFagron Compounding Services
classificationClass II
statusOngoing
distributionNationwide in the U.S.A.
productVancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266
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