Drug 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.
D-0099-2026
Product summary
- Event
- Event 97710
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,518 packs (11,036 Syringes) 2 syringes/carton)
- Official record key
drug-enforcement:D-0099-2026
Official wording
Reason: Lack of Assurance of Sterility.
Code information: Lot: F2505017, Expiry: 24-Jan-2027
Distribution pattern: Distributed only to one warehouse in NJ. with no further distribution
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility