FDA-Drug2025-11-05Class II
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.
Samsung Bioepis Co., Ltd.
Hazard
Lack of Assurance of Sterility.
Sold states
Distributed only to one warehouse in NJ. with no further distribution
Affected count
5,518 packs (11,036 Syringes) 2 syringes/carton)
Manufactured in
76 Songdogyoyuk-Ro, N/A, Yeonsu, N/A, Korea (the Republic of)
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0099-2026Don't want to check this manually?
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