Drug recall for a mistake that may cause ‘persistent diarrhea’ and ‘potentially death’
About 2,751 Firvanq Vancomycin 50 mg/mL Kits, used to treat clostridium difficile-associated diarrhea and enterocolitis, got recalled by Azurity Pharmaceuticals because some kits have the wrong diluent.
The kits should have a bottle of Firvanq, a brand name for vancomycin hydrochloride, USP powder and a bottle of grape-flavored diluent. But some of the recalled kits have diluent that goes with First Omeprazole instead of Firvanq.
The First Omeprazole diluent might not solubilize the Firvanq properly, the Azurity-written, FDA-posted recall says. This can have serious consequences:
“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.”
The recalled lot is No. 21035, with an expiration date of 2022-07-31. The medication’s NDC No. is 65628-206-05 and the UPC code is 3 65628 206005 1.
Patients and retailers should return the recalled Firvanq to the place of purchase. Distributors should quarantine it.
If this or any drug causes a problem, after notifying a medical professional, let the FDA know via its MedWatch Adverse Event page or by filling out a form you can get by calling 800-332-1088. Only then do you notify the drug company.
Patients with recall questions can reach out to Azurity Senior Manager Koral Couch by email (kcouch@azurity.com), phone (781-935-8141, extension 119, Monday through Friday, 8:30 a.m. to 5 p.m., Eastern time) or fax (781-935-8395).
This story was originally published September 9, 2021 at 9:27 AM with the headline "Drug recall for a mistake that may cause ‘persistent diarrhea’ and ‘potentially death’."
