August 2021 FDA Recall Firvanq by Azurity Pharmaceuticals, Inc.
D-0003-2022 - Product Mix-up
This Class I drug recall was voluntarily initiated by Azurity Pharmaceuticals, Inc. on August 24, 2021 for the product Firvanq. The FDA reported the reason for recall as product mix-up. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0003-2022
Product Mix-up: Incorrect diluent component included in the kit.
08-24-2021
10-13-2021
2,751 kits
Recall Profile & Regulatory Data
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Azurity Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA nationwide
05-12-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of 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.
Batch or Lot Expiration Information
Lot# 21035, Exp 7/31/2022
