Glycopeptide Antibacterial Treatment Under Class I Recall

A recall for a single lot of Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kits has been designated Class I by the US Food and Drug Administration (FDA). According to a company announcement from recalling firm Azurity Pharmaceuticals Inc., some kits in the lot contain a First Omeprazole (FIRST-PPI) diluent instead of the Firvanq diluent. 

The most serious FDA recall, Class I warns that use of affected products could result in serious adverse health consequences or death. 

“Vancomycin may not be completely solubilized in the FIRST-PPI diluent, which could lead to doses above or below those recommended in the label,” Azurity Pharmaceuticals stated in the September 8, 2021, announcement. “There is reasonable probability that the administration of inappropriate doses of oral vancomycin may lead to persistent diarrhea associated with dehydration and electrolyte abnormalities, recurrence of Clostridium difficile (C difficile) infection, its progression to severe colitis, colon perforation requiring colectomy, and potentially death.” 

Patients who are older or immunocompromised are especially vulnerable to complications of C. difficile, the announcement explained.

The recall spans a total 2751 Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kits (NDC 65628-206-05) from lot 21035 (Exp. 7/31/22). Each kit includes a bottle of vancomycin hydrochloride powder for oral solution and a bottle of grape-flavored diluent for reconstitution. The kits were manufactured for Azurity Pharmaceuticals, Wilmington, MA, and distributed throughout the United States. 

“Consumers, distributors, and retailers that are in possession of Firvanq from the affected lot should immediately stop using it and return it to the place of purchase,” Azurity Pharmaceuticals advised. “Distributors are asked to place any affected product under quarantine and return it promptly to Azurity.” 

Azurity Pharmaceuticals voluntarily initiated the recall August 24, 2021. The FDA categorized it Class I on October 5, 2021. The recall was included in the October 13, 2021, FDA Enforcement Report.

Firvanq is available with a prescription for the treatment of adult and pediatric patients with C difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus.