Hikma Pharmaceuticals USA Inc. is recalling 31,400 bags of Acetaminophen Injection (1,000 mg per 100 mL) because some packages may contain a different drug entirely. A bag of Dexmedetomidine HCl (a powerful sedative) was found inside an overwrap labeled as Acetaminophen. This labeling error means a patient could be accidentally administered the wrong medication intravenously.
If a patient is accidentally given Dexmedetomidine instead of Acetaminophen, they may experience unintended sedation, a significantly slowed heart rate, or dangerously low blood pressure. These effects can be life-threatening, particularly in critically ill patients.
A bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection.
“Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) 100 mL, For Intravenous Use Only, product label”
“Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 10 x 100 mL, single dose flexible containers, carton label”
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.
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Sources: FDA iRES · FDA Press Release · Raw API Response
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