Drug recall D-0339-2026
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,
Reason for recall
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.
Lots and codes
Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027.
Recall details
- Recalling firm
- LEO PHARMA INC, Madison, NJ
- Quantity
- 11,407 units
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 10, 2026
Related products
- Adbry – drug information
- NDC 50222-350 Adbry · Tralokinumab 300 mg/2mL · LEO Pharma Inc.
- NDC 50222-346 Adbry · Tralokinumab 150 mg/mL · LEO Pharma Inc.