FDARecalled Nov 5, 2025 · #D-0099-2026
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, Manufactu...
Hazard
Class II — temporary health risk
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Lack of Assurance of Sterility. Classification: Class II Distribution: Distributed only to one warehouse in NJ. with no further distribution
Product details
- 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.
- Type
- Drugs
- Manufacturer
- Samsung Bioepis Co., Ltd.
- Model numbers
- F2505017
- UPCs
- —