Drug Safety Alerts

Firvanq Voluntary Recall

9/8/2021

On September 8, 2021, the United States Food and Drug Administration (FDA) published a notice regarding a consumer-level recall of Firvanq® (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit. This recall was issued because some products in the affected lot have been found to incorrectly contain a First Omeprazole (FIRST-PPI) diluent instead of the Firvanq® diluent bottle.

This recall affects NDC number 65628-0206-05, lot number 21035 exp. 07/31/2022. No other lots are affected by this recall.

This could be a health hazard or safety risk to patients who may be using product affected by this recall.

According to Azurity, vancomycin may not be completely solubilized in the FIRST-PPI diluent which could lead to doses above or below those recommended in the label. 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. Especially, the elderly and immunocompromised patients are vulnerable to the complications of C. difficile infection.

Azurity reports that to date it has not received any reports of adverse events related to this recall.

Firvanq® is indicated for use in adults and pediatric patients less than 18 years of age for the treatment of: Clostridium 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 65628-0206-05 and the UPC code is 3 65628 206005 1. A total of 2,751 kits of the affected Firvanq®, lot number 21035, with an expiration date of 2022-07-31 were distributed. The product can be identified by its brand name Firvanq®. Product was distributed nationwide through wholesale distributors.

Azurity recommends that patients immediately stop using Firvanq® (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit that is affected by this recall.

CVS Caremark Response: Because of this action, CVS Caremark Specialty Pharmacy is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are using Firvanq® (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit to contact their prescriber.

For more information about Firvanq® (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, please call Koral Couch at 781 935-8141, ext. 119 or email them at kcouch@azurity.com. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.