Azurity Pharmaceuticals, Inc.: Drug Recall

Recall #D-0003-2022 · 08/24/2021

Class I: Dangerous

Recall Details

Recall Number: D-0003-2022
Classification: Class I
Product Type: Drug
Recalling Firm: Azurity Pharmaceuticals, Inc.
Status: Terminated
Date Initiated: 08/24/2021
Location: Wilmington, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2,751 kits

Reason for Recall

Product Mix-up: Incorrect diluent component included in the kit.

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.

Distribution Pattern

USA nationwide

Other Recalls by Azurity Pharmaceuticals, Inc.

Class I: Dangerous 01/04/2024

Labeling: Label Mix-up
Class III: Low Risk 12/08/2023

Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Class II: Risk 02/15/2023

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

View all recalls by Azurity Pharmaceuticals, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.