WASHINGTON (dpa-AFX) - Azurity Pharmaceuticals, Inc. is recalling one lot of Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit to the consumer level due to a mix-up of the diluent, the U.S. Food and Drug Administration said.
The company has distributed a total of 2,751 kits of the affected Firvanq, lot number 21035, with an expiration date of 2022-07-31.
Firvanq is indicated for use in adults and pediatric patients less than 18 years of age for the treatment of Clostridium difficile or C. difficile-associated diarrhea and Enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains.
It is packaged as a kit consisting of a bottle with Vancomycin Hydrochloride, USP powder, a bottle of Grape-Flavored diluent, and Full Prescribing Information. The product NDC is 65628-206-05 and the UPC code is 3 65628 206005 1.
The product was distributed nationwide through wholesale distributors.
According to the agency, some products in the affected lot have been found to incorrectly contain a First Omeprazole or FIRST-PPI diluent instead of the Firvanq diluent bottle.
Vancomycin may not be completely solubilized in the FIRST-PPI diluent which could lead to doses above or below those recommended in the label.
The administration of inappropriate doses of oral vancomycin is likely to cause 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 mainly vulnerable to the complications of C. difficile infection.
However, the Wilmington, Massachusetts -based Azurity has not received any reports of adverse events related to this recall to date.
Consumers, distributors, and retailers that are in possession of Firvanq from the affected lot are asked to stop using it and return it to the place of purchase.
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