D-0099-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- November 5, 2025
- Initiation Date
- October 10, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,518 packs (11,036 Syringes) 2 syringes/carton)
Product Description
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.
Distribution Pattern
Distributed only to one warehouse in NJ. with no further distribution
Code Information
Lot: F2505017, Expiry: 24-Jan-2027