Akcea Therapeutics, Inc. is recalling 450 cartons of Tegsedi (inotersen) Injection 284 mg/1.5 mL, a prescription medication used for subcutaneous injection. The medication was found to be superpotent, meaning the concentration of the active ingredient is higher than what is stated on the label. While no injuries or adverse events have been reported to date, using a superpotent drug can lead to a higher-than-intended dosage. Patients should contact their healthcare provider or pharmacist regarding this recall and return any unused medication for a refund.
A superpotent medication contains more of the active ingredient than intended, which can increase the risk of side effects or toxic reactions associated with the drug. Because this medication is administered by injection, an incorrect dosage could have serious health implications.
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Distributed by Sobi, Inc. Each prefilled syringe contains 284 mg of inotersen (equivalent to 300 mg inotersen sodium in 1.5 ml of solution).
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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