Class II
Ongoing
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.
- Company
- Samsung Bioepis Co., Ltd.
- Recall Initiated
- October 10, 2025
- Posted
- November 5, 2025
- Recall Number
- D-0099-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 5,518 packs (11,036 Syringes) 2 syringes/carton)
- Firm Location
- Yeonsu, Korea (the Republic of)
Reason for Recall
Lack of Assurance of Sterility.
Distribution
Distributed only to one warehouse in NJ. with no further distribution
Lot / Code Info
Lot: F2505017, Expiry: 24-Jan-2027
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