The recommended maximum daily dose of Vancomycin is up to 2 grams a day. The overfilled vials could result in patients receiving up to 4 grams a day.
Amneal Pharmaceuticals is recalling 4 lots of Vancomycin Hydrochloride for oral solution 250 mg/5mL because the bottles may have been overfilled, which can result in patients receiving a higher than recommended dose. The error occurred during the manual bottle filling stage of manufacturing.
Vancomycin Hydrochloride is administered orally to treat patients with enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by C. difficile. Enterocolitis is an inflammatory condition of the small and large intestine. Pseudomembranous colitis is severe inflammation of the inner lining of the large intestine.
The recommended maximum daily dose is up to 2 grams a day. The overfilled vials could result in patients receiving up to 4 grams a day. This could be harmful to patients with renal insufficiency. Worsening renal function could be associated with electrolyte abnormalities such as high potassium leading to cardiac arrest.
Patients with inflammatory disorders of the intestinal may be at risk for the development of adverse reactions associated with higher doses of vancomycin oral solution.
To date, Amneal has not received any reports of adverse events related to this recall.
The lots impacted by this recall all have a September 2025 expiration date and include:
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
Read More
FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Read More