Firvanq Kit
FDA Recall NDC 65628-208
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Firvanq (NDC 65628-208). A significant event, classified as Class I, was initiated on Aug 24, 2021 by Azurity Pharmaceuticals, Inc. The reported reason for this action was: "Product Mix-up: Incorrect diluent component included in the kit."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
Product Mix-up: Incorrect diluent component included in the kit.
Aug 24, 2021
Oct 13, 2021
2,751 kits
Recall Profile & Regulatory Data
Event ID
88547
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Azurity Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide
Termination Date
May 12, 2022
Product Description
Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle containing 7.7 g Vancomycin Hydrochloride USP, powder for oral solution and 1 bottle containing 145 mL Grape Flavored Diluent for reconstitution per carton, Rx only, Manufactured for: Azurity pharmaceuticals, Wilmington, MA 01887, NDC 65628-206-05.
Batch or Lot Expiration Information
Lot# 21035, Exp 7/31/2022
Affected Packages Involved in this Recall
65628-204-05Product
65628-205-10Product
65628-206-05Product
65628-208-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
