FDA DrugClass IINotable
FDA Recall: Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPL
Description
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.
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.
Remedy
11,407 units
Related Recalls
2026-08-05 · FDA_DRUG
FDA Recall: Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack, Rx only, Manufactured by: Alkem
Ascend Laboratories, LLC
2026-08-05 · FDA_DRUG
FDA Recall: Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharma
Glenmark Pharmaceuticals Inc., USA
2026-08-05 · FDA_DRUG
FDA Recall: Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manuf
MICRO LABS USA INC
2026-08-05 · FDA_DRUG
FDA Recall: Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only,
MYLAN PHARMACEUTICALS INC