FDA Drug Class II — Moderate

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.

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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
Brand
Samsung Bioepis Co., Ltd.
UPC
Lot: F2505017, Expiry: 24-Jan-2027

Units Affected

5,518 packs (11,036 Syringes) 2 syringes/carton)

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