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🏥 FDA: LEO PHARMA INC — Class II

healthcareneutralSource: FDA
80%Confidence
0Views
FDASource
2026-03-16Date

Summary

LEO Pharma's recall of Adbry due to wool fiber contamination is a specific sterility issue for a biologic drug, which could impact patient trust and sales. However, as a single-lot issue from an established company, the broader market impact may be contained.

Actionable: Watch for any follow-up FDA inspections or communications regarding LEO Pharma's manufacturing site.

AI Confidence: 80%

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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