Amneal Pharmaceuticals is recalling 4 lots of Vancomycin Hydrochloride for Oral Solution USP, 250 mg/ 5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, because some bottles may have been overfilled which can result in an over potent dosing regimen. The recommended maximum daily dose allowance for this product is up to 2 gm/day and patients prescribed a dosing regimen of 500 mg/ 10mL would exceed this daily allowance, which may be harmful to patients with renal insufficiency. The error occurred during the manual bottle filling stage of manufacturing.
Adult patients who are prescribed the maximum daily dose of up to 2 grams per day of Vancomycin Hydrochloride for Oral Solution, USP 250 mg/ 5mL, may receive up to 4 grams of oral vancomycin per day because of the overfilled bottle. Some patients with inflammatory disorders of the intestinal mucosa also may have significant systemic absorption of vancomycin. These patients may be at risk for the development of adverse reactions associated with higher doses of vancomycin oral solution. Worsening renal function could be associated with electrolyte abnormalities such as high potassium leading to cardiac arrest.
To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall.
Vancomycin Hydrochloride for Oral Solution USP, 250 mg/ 5mL, is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic- associated pseudomembranous colitis caused by C. difficile.
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