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🏥 FDA: LEO PHARMA INC — Class II

healthcareneutralSource: FDA
88%Confidence
0Views
FDASource
2026-03-11Date

Summary

Recall of Adbry autoinjectors by LEO Pharma due to wool fiber contamination is a specific sterility issue affecting a high-value biologic for atopic dermatitis. While limited to one lot, it highlights supply chain vulnerabilities for injectable products.

Actionable: Confirm with LEO Pharma the lot numbers affected and ensure healthcare providers check inventory to remove any contaminated units.

AI Confidence: 88%

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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