Eugia US LLC is recalling 70,125 vials of Dexamethasone Sodium Phosphate injection USP (120mg per 30mL), distributed under the AuroMedics Pharma brand. This corticosteroid medication was found to contain an impurity called sulfonic acid adduct of dexamethasone phosphate at levels higher than the approved safety specifications. Using a medication with excessive impurities can lead to unexpected side effects or reduce the effectiveness of the treatment. Healthcare providers and facilities should isolate any remaining vials from the affected lots and contact the manufacturer to arrange for a return.
The injection contains chemical impurities that exceed safety thresholds, which may increase the risk of unpredictable adverse reactions for patients receiving the medication.
Distributed by AuroMedics Pharma LLC.
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.
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Sources: FDA iRES · Raw API Response
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