Azurity Pharmaceuticals is voluntarily recalling 1 lot of Firvanq® (vancomycin hydrochloride for oral solution) as some kits were found to incorrectly contain the First Omeprazole (FIRST-PPI) diluent.
Firvanq is indicated for the treatment of Clostridium difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adults and pediatric patients.
A total of 2751 kits of the recalled lot, Firvanq; NDC 65628-206-05; UPC code 3 65628 206005 1; Lot Number 21035; Expiration date 7/31/2022, were distributed nationwide. The kit contains a bottle of vancomycin hydrochloride, USP powder, and a bottle of grape-flavored diluent.
Use of the incorrect diluent could potentially lead to doses above or below the recommended amount as vancomycin may not be completely solubilized in the FIRST-PPI diluent. Patients administered inappropriate doses of oral vancomycin may experience persistent diarrhea and recurrence of Clostridium difficile infection. To date, the Company has not received any reports of adverse events.
Consumers with questions related to this recall may contact Koral Couch, Senior Manager, Customer Service by phone: (781) 935-8141 ext. 119; fax: (781) 935-8395 or email: [email protected].
Adverse events or quality issues should be reported to the Food and Drug Administration’s MedWatch Adverse Event Reporting program.
Azurity Pharmaceuticals, Inc. issues voluntary nationwide recall of one lot of Firvanq® (vancomycin hydrochloride for oral solution), Vancomycin 50mg/mL Kit, due to a mix-up of the diluent included in the kit. News release. US Food and Drug Administration. Accessed September 9, 2021. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/azurity-pharmaceuticals-inc-issues-voluntary-nationwide-recall-one-lot-firvanqr-vancomycin.