If You Use This Medication, Stop Immediately, FDA Says
The medicine could pose a serious health risk to those who use it, the authority cautions.
Getting a new prescription from your doctor can be both a relief and nerve-racking at once. While you're hopeful it will help with the condition it's supposed to treat, you may also find yourself nervous about the potential side effects associated with your new medication. In the case of one particular medication, those prescribed it have extra reason for concern, now that the U.S. Food & Drug Administration (FDA) is recommending that anyone who takes it stop immediately due to the health risk it presents. Read on to find out if your medication could be putting you in harm's way.
A medication used to treat digestive issues is being recalled.
On Sept. 8, the FDA announced that Azurity Pharmaceuticals, Inc. is voluntarily recalling 2,751 kits of Firvanq 50 mg/mL from lot number 21035. The medication, used to treat diarrhea associated with Clostridium difficile and enterocolitis associated with staphylococcus aureus, can be identified by NDC number 65628-206-05, UPC number 3 65628 206005 1, and expiration date 2022-07-31.
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The medication kits contain the incorrect dilutant.
Firvanq kits are supposed to contain Vancomycin Hydrochloride, USP powder, and a grape-flavored dilutant.
The Firvanq kits in the recalled lot are accompanied by a bottle of First Omeprazole, a medication used to treat overproduction of acid in the stomach, instead of the appropriate dilutant.
According to Azurity Pharmaceuticals, the inclusion of the incorrect dilutant with the kits may pose a serious health risk to individuals using the recalled Firvanq lot.
The inclusion of the omeprazole may result in serious health issues.
Azurity Pharmaceuticals explains that inclusion of the incorrect dilutant "could lead to doses above or below those recommended in the label."
They add that there's "reasonable probability" that these incorrect doses can lead to a whole host of issues, including "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," the company explains.
Individuals with compromised immune systems and older adults are particularly at risk of complications, although at the time the recall was announced, no adverse effects related to use of the affected medication had been reported.
If you have the recalled medication at home, don't use it.
If you are in possession of one of the recalled Firvanq kits and are experiencing symptoms, contact a healthcare provider immediately. Azurity Pharmaceuticals says anyone with the recalled medication should stop using it immediately and return it to the pharmacy or medical office from which it was purchased.
Azurity Pharmaceuticals is also reaching out to customers and distributors to arrange for the recalled products' return.
If you have questions related to the recall, contact Azurity Pharmaceuticals Senior Manager of Customer Services Koral Couch at 781-935-8141 x 119 from 8:30 a.m. to 5 p.m. ET or at [email protected] anytime.