Recall D-0099-2026

US Class II Ongoing · initiated 2025-10-10

Recalling firm

Samsung Bioepis Co., Ltd.

Product

HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302, Manufactured by: SAMSUN BIOEPIS Co., Ltd, Incheon, Republic of Korea, NDC 78206-183-01.

Reason for recall

Lack of Assurance of Sterility.

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