• Drug Coverage
  • Hypertrophic Cardiomyopathy (HCM)
  • Vaccines: 2023 Year in Review
  • Eyecare
  • Urothelial Carcinoma
  • Women's Health
  • Hemophilia
  • Heart Failure
  • Vaccines
  • Neonatal Care
  • Type II Inflammation
  • Substance Use Disorder
  • Gene Therapy
  • Lung Cancer
  • Spinal Muscular Atrophy
  • HIV
  • Post-Acute Care
  • Liver Disease
  • Pulmonary Arterial Hypertension
  • Safety & Recalls
  • Biologics
  • Asthma
  • Atrial Fibrillation
  • Type I Diabetes
  • RSV
  • COVID-19
  • Cardiovascular Diseases
  • Breast Cancer
  • Prescription Digital Therapeutics
  • Reproductive Health
  • The Improving Patient Access Podcast
  • Blood Cancer
  • Ulcerative Colitis
  • Respiratory Conditions
  • Multiple Sclerosis
  • Digital Health
  • Population Health
  • Sleep Disorders
  • Biosimilars
  • Plaque Psoriasis
  • Leukemia and Lymphoma
  • Oncology
  • Pediatrics
  • Urology
  • Obstetrics-Gynecology & Women's Health
  • Opioids
  • Solid Tumors
  • Autoimmune Diseases
  • Dermatology
  • Diabetes
  • Mental Health

Amneal Recalls 4 Lots of Vancomycin Because of Overfilling


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:

  • Lot no. 22613003A with NDC 69238-2261-3; 80 mL
  • Lot no. 22613004A with NDC 69238-2261-7; 150 mL
  • Lot no. 22613005A with NDC 69238-2261-7; 150 mL
  • Lot no. 22613005B with NDC 69238-2261-5; 300 mL
Related Videos
Related Content
© 2024 MJH Life Sciences

All rights reserved.