Samsung Bioepis Co., Ltd. has recalled 5,518 packs (11,036 total syringes) of Hadlima (adalimumab-bwwd) injection, 40mg/0.8 mL. The recall was initiated because the manufacturer cannot guarantee the sterility of the injectable medication. Hadlima is a prescription biologic used to treat inflammatory conditions like rheumatoid arthritis and Crohn's disease, and using a non-sterile injectable can lead to serious infections. The affected products were distributed to a single warehouse in New Jersey.
A lack of assurance of sterility means the injectable medication may contain microorganisms like bacteria or fungi. Injecting a contaminated product directly into the body can cause severe, potentially life-threatening systemic infections or localized abscesses at the injection site.
You have 2 options:
2 Single-dose Prefilled Syringes per carton. Manufactured for Organon LLC by Samsung Bioepis Co., Ltd.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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