Azurity Recalls its Firvanq® Vancomycin 50 mg/mL Kit Due to Incorrect Diluent
According to the FDA, Azurity Pharmaceuticals, Incorporated (“Azurity”) is recalling “one lot of Firvanq® (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit (“Firvanq”).” The recall is at the consumer level. The lot of Firvanq (vancomycin hydrochloride for oral solution) is being recalled due to the wrong diluent being packaged with the kit. The kit was supposed to include a Firvanq diluent bottle but was instead packaged with a First Omeprazole (FIRST-PPI) diluent.
The Risk Statement says that Vancomycin cannot be completely solubilized in the FIRST-PPI diluent, and this can lead to patients receiving doses below or above the label’s recommended dose. This error could lead to symptoms such as persistent diarrhea, dehydration, electrolyte abnormalities, Clostridium difficile infection, severe colitis, colon perforation that requires colectomy, and death. Immunocompromised patients and the elderly are more vulnerable to complications stemming from a C. difficile infection.
Firvanq is packaged as a kit containing a bottle of grape-flavored diluent, a bottle with Vancomycin Hydrochloride, Full Prescribing Information, and USP powder. The recalled product’s UPC code is 3 65628 206005 1, NDC is 65628-206-05, the lot number is 21035, with has an expiration date of 2022-07-31. The product is also identified by the brand name Firvanq.
Azurity is notifying its distributors and customers by direct notifications to distributors and via this press release. Azurity is arranging for return and replacement of only recalled products. 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. Distributors are asked to place any affected product under quarantine and return it promptly to Azurity.
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