Somerset Therapeutics LLC is recalling 62,190 vials of Dexamethasone Sodium Phosphate Injection, USP (100 mg/10 mL), a prescription steroid medication. Testing at the product's 24-month expiration date revealed levels of impurities and degradation products, specifically dexamethasone formate and Dexamethasone Sodium Phosphate EP impurity G, that were higher than safety specifications allow. This drug is commonly used to treat inflammation and various conditions such as allergic disorders, skin diseases, and breathing problems.
The presence of elevated impurities over time means the medication no longer meets established quality standards for purity. While no specific injuries have been reported, using medication that has degraded or contains excessive impurities may reduce the treatment's effectiveness or lead to unexpected side effects.
Manufactured for Somerset Therapeutics, 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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