United StatesAdbry (tralokinumab-ldrm) injection 300 mg/2 mL autoinjector — packaged as 1× single‑dose autoinjector (SAMPLE NOT FOR SALE), NDC 50222‑350‑91, or 2× single‑dose autoinjectors, NDC 50222‑350‑02 — lots 003E24C and 003E24A, exp. 04/30/2027, distributed nationwide in the United States, is being recalled by Leo Pharma Inc. The recall was initiated for lack of assurance of sterility after laboratory testing identified particulate matter (wool fiber) in one unit.
What's being recalled
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,
Recalling firm: Leo Pharma Inc, Madison, NJ, United States.
How to identify it
Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027.
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide in the USA
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)