Recall Enforment Report D-0003-2022

Drug Recall Enforcement Report Class I voluntary initiated by Azurity Pharmaceuticals, Inc., originally initiated on 08-24-2021 for the product 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. The product was recalled due to product mix-up: incorrect diluent component included in the kit.. The product was distributed nationwide and the recall is currently ongoing.

Field Name Field Value
Event ID 88547 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-0003-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern USA nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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.
Reason For Recall Product Mix-up: Incorrect diluent component included in the kit. What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 2,751 kits Product Quantity
The amount of product subject to recall.
Voluntary Mandated Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date 10-13-2021
Recall Initiation Date 08-24-2021 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type Drugs
Recalling Firm Azurity Pharmaceuticals, Inc.
Code Info Lot # 21035, Exp 7/31/2022 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages 65628-204-05; 65628-205-10; 65628-206-05; 65628-208-10
Status Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
65628-204Firvanq Vancomycin HydrochlorideKitAzurity Pharmaceuticals, IncHuman Prescription Drug
65628-205Firvanq Vancomycin HydrochlorideKitAzurity Pharmaceuticals, IncHuman Prescription Drug
65628-206Firvanq Vancomycin HydrochlorideKitAzurity Pharmaceuticals, IncHuman Prescription Drug
65628-208Firvanq Vancomycin HydrochlorideKitAzurity Pharmaceuticals, IncHuman Prescription Drug