Reported Mar 4, 2026 · Ongoing
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC…
Leo Pharma Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LEO PHARMA INC · 7 Giralda Farms · Madison, NJ · 07940-1051
Is this the product you have?
- 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 55DK-2750 BallerupDenmark
- Distributed byLEO Pharma Inc., Madison, NJ 07940, USA
- Lot codes and dates
- Lot
a) 003E24CExp 04/30/2027b) 003E24AExp 04/30/2027
- Lot
- Amount recalled
- 11,407 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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