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🏥 FDA: LEO PHARMA INC — Class II

healthcarebearishSource: FDA
82%Confidence
0Views
FDASource
2026-03-10Date

Summary

LEO Pharma recalls Adbry due to wool fiber contamination, a Class II sterility issue for a biologic injection. This specific particulate matter points to potential packaging or environmental control failures during manufacturing.

Actionable: Evaluate LEO Pharma's quality control response and monitor for any impact on Adbry's market share against competing atopic dermatitis treatments.

AI Confidence: 82%

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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