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🏥 FDA: LEO PHARMA INC — Class II

healthcareactionableSource: FDA
87%Confidence
0Views
FDASource
2026-03-15Date

Summary

LEO Pharma recalls Adbry autoinjectors due to wool fiber contamination, a sterility issue that could compromise the biologic's integrity. This Class II recall may disrupt treatment for atopic dermatitis patients and requires investigation into packaging processes.

Actionable: Monitor LEO Pharma's corrective actions and assess any potential supply chain delays for Adbry in the dermatology market.

AI Confidence: 87%

Data Points

firmLEO PHARMA INC
classificationClass II
statusOngoing
distributionNationwide in the USA
productAdbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single do

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