One lot of the vancomycin kits mistakenly contained a first omeprazole diluent.
Azurity Pharmaceuticals has recalled voluntarily 1 lot of vancomycin hydrochloride for oral solution 50 mg/mL Kit (Firvanq) to the consumer level due to some affected lots found to incorrectly contain a first omeprazole (FIRST-PPI) diluent rather than the vancomycin diluent bottle.
The vancomycin might not be completely solubilized in the incorrect diluent, which could lead to doses above or below what is recommended on the label, which could lead to the administration of inappropriate doses that can cause persistent diarrhea associated with dehydration and electrolyte abnormalities, recurrence of Clostridium difficile infection, the progression to severe colitis, colon perforation requiring colectomy, and potentially death.
This could leave high risk populations, particularly older individuals and immunocompromised patients, vulnerable to the complications of CDI.
At the time of the recall, Azurity has said there have been no reports of adverse events related to the recall.
Currently, the treatment is approved by the US Food and Drug Administration (FDA) and indicated for both adults and pediatric patients for the treatment of C difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains.
The treatment kit includes a bottle with Vancomycin Hydrochloride, USP powder, a bottle of grape-flavored diluent, and full prescribing information.
The company is notifying distributors and customers and arranging for the return and replacement of the recalled products.