Drug product

Adbry, (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 dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA,

D-0339-2026

February 10, 2026

Class II

Product summary

Firm: LEO PHARMA INC
Event: Event 98401
Status: Ongoing
Classification: Class II
Quantity: 11,407 units
Official record key: drug-enforcement:D-0339-2026

Official wording

Reason: Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.

Code information: Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027.

Distribution pattern: Nationwide in the USA

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

particulate matter
Sterility assurance
reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility