Medications & Supplements/Prescription Drugs

Firvanq Oral Solution Kit Recalled for Product Mix-up

Agency Publication Date: October 5, 2021

Summary

Firvanq (vancomycin hydrochloride) 50 mg/mL Oral Solution Kits are being recalled because they may contain the incorrect diluent component used for mixing the medication. Approximately 2,751 kits are affected by this product mix-up. The recall involves kits manufactured by Azurity Pharmaceuticals, Inc. that were distributed to pharmacies and healthcare providers nationwide.

Risk

The inclusion of an incorrect diluent could result in a medication that does not meet safety or efficacy standards for treating serious infections. No incidents or injuries have been reported in connection with this recall.

What You Should Do

This recall affects Firvanq (vancomycin hydrochloride) 50 mg/mL Oral Solution Kits with NDC 65628-206-05, specifically lot 21035 with an expiration date of 7/31/2022.
If you have health concerns, contact your healthcare provider or pharmacist.
Return any unused product to the place of purchase for a refund, throw it away, or contact Azurity Pharmaceuticals, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Firvanq (vancomycin hydrochloride for oral solution) 50 mg/mL Kit

Variants: 50 mg/mL, Oral Solution Kit, 7.7 g Vancomycin Hydrochloride USP powder, 145 mL Grape Flavored Diluent

Lot Numbers:

21035 (Exp 7/31/2022)

NDC:

65628-206-05

Each kit includes one bottle of powder and one bottle of diluent for reconstitution.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88547

Status: Resolved

Manufacturer: Azurity Pharmaceuticals, Inc.

Sold By: Pharmacies; Healthcare Providers

Manufactured In: United States

Units Affected: 2,751 kits

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.