X-Gen Pharmaceuticals is recalling 24,966 vials of Clonidine Hydrochloride Injection, 1000 mcg/10mL (100 mcg/mL), because the side panel of the carton incorrectly lists the concentration as 500 mcg per mL. The actual concentration of the medication is 100 mcg per mL, creating a risk of dosing confusion. This prescription medication is a single-dose vial used for injection and was distributed nationwide in the United States.
The discrepancy between the side panel and the actual concentration could lead to healthcare providers administering an incorrect dose of the medication. Clonidine is a potent drug, and incorrect dosing can lead to serious cardiovascular or neurological side effects.
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Sources: FDA iRES · Raw API Response
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