FDA-Drug2025-11-05Class IIPROCESSING DEFECT
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.
Hazard
Lack of Assurance of Sterility.
Who it affects
Adults
Illnesses reported
None reported
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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