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September 8, 2021 – Azurity Pharmaceuticals has recalled one lot of Firvanq® (vancomycin hydrochloride for oral solution), Vancomycin 50mg/mL Kit. Some of the kits in the lot have incorrectly contain a First Omeprazole (FIRST-PPI) diluent instead of the Firvanq diluent bottle.
- There is no impact to members through Benecard Central Fill.
- Firvanq is U.S. FDA approved to treat Clostridium difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus. It is packaged as a kit that includes a bottle of vancomycin hydrochloride powder and a bottle of grape-flavored diluent.
- Preparing Firvanq for administration with the FIRST-PPI diluent could cause the medication’s dose to be too low or too high. This could lead to persistent diarrhea associated with dehydration and electrolyte abnormalities, recurrence of C. difficile infection, progression to severe colitis, colon perforation requiring colectomy, and possibly death. As of the recall date, Azurity had not received any reports of adverse events related to the affected product.
- According to Azurity, any consumers, distributors, or retailers currently in possession of the recalled Firvanq should immediately stop using the product and return it to the place of purchase. The affected product belongs to lot number 21035 and has an expiration date of 2022-07-31.
- Questions regarding the recall should be directed to Azurity via Koral Couch, Senior Manager,
Customer Service, at:
- Phone: 1-781-935-8141, ext. 119
- Fax: 1-781-935-8395
- Email: kcouch@azurity.com
- Azurity asks individuals to contact their healthcare provider if they have experienced problems that may be related to use of the recalled Firvanq.
- A copy of the full recall announcement is available on the FDA's website.