Warning
Samsung Bioepis Co. Recalls HADLIMA (adalimumab-bwwd) injection
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0099-2026Drug / Pharmaceutical
Samsung Bioepis Co. Recalls HADLIMA (adalimumab-bwwd) injection
Samsung Bioepis Co., Ltd. · Class II — Moderate Risk
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Distributed only to one warehouse in NJ. with no further distribution
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database