FDA is Recalling One Lot of Firvanq

The lot contains kits with the incorrect solution for diluting vancomycin, which could lead to doses above or below recommended levels.

Azurity Pharmaceuticals is voluntarily recalling one lot of Firvanq (vancomycin hydrochloride for oral solution) kit because some products in the lot have been found to contain the wrong solution for diluting. Instead, the kits contain First Omeprazole (FIRST-PPI), a diluent that is included in compounding kit for the treatment of gastric and duodenal ulcers, esophagitis, and gastroesophageal reflux disease.

Firvanq is used to treat patients who have Clostridium difficile-associated diarrhea and Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains).

Vancomycin may not be completely solubilized in the FIRST-PPI diluent, which could lead to doses above or below those recommended in the label. Inappropriate doses of vancomycin may lead to persistent diarrhea associated with dehydration and electrolyte abnormalities, recurrence of C. difficile infection, its progression to severe colitis, colon perforation requiring colectomy, and potentially death. The elderly and immunocompromised patients are vulnerable to the complications of C. difficile infection.

To date, Azurity has not received any reports of adverse events related to this recall.

Firvanq is packaged as a kit consisting of a bottle with vancomycin hydrochloride, USP powder and a bottle of Grape-Flavored diluent. The product NDC is 65628-206-05 and the UPC code is 3 65628 206005 1.

A total of 2,751 kits, lot number 21035, with an expiration date of 2022-07-31 were distributed. The product was distributed nationwide through wholesale distributors.