FDA-Drug2026-03-04Class IIPROCESSING DEFECT
Adbry (tralokinumab-ldrm) injection recalled for particulate contamination
Nationwide distributionDrugs
What this means
LEO Pharma is recalling specific lots of Adbry, a prescription injection used to treat atopic dermatitis, because one unit was found to contain wool fiber particles. This contamination raises concerns about sterility and safety. No injuries have been reported so far.
- Check if you have Adbry from lot 003E24C (expires 04/30/2027) or lot 003E24A (expires 04/30/2027)
- Do not use the medication if it matches these lot numbers
- Contact your pharmacy or prescriber for a replacement or alternative treatment
- Call LEO Pharma or the FDA with questions about your specific lot
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA
Affected count
11,407 units
Manufactured in
7 Giralda Farms, N/A, Madison, NJ, United States
Products
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,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0339-2026Want us to check the next one for you?
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