Home / Recalls / Azurity Pharmaceuticals, Inc. / D-0003-2022

D-0003-2022 Class I Terminated

Recalled by Azurity Pharmaceuticals, Inc. — Wilmington, MA

FDA drug recall D-0003-2022 was initiated by Azurity Pharmaceuticals, Inc. on Aug 24, 2021 and is designated Class I. Reason for recall: Product Mix-up: Incorrect diluent component included in the kit. The recall status is terminated (terminated May 12, 2022). Affected quantity: 2,751 kits.

Recall details

Product Type: Drugs
Report Date: Oct 13, 2021
Initiation Date: Aug 24, 2021
Termination Date: May 12, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2,751 kits

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.

Distribution pattern

USA nationwide

Code information

Lot # 21035, Exp 7/31/2022

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0003-2022
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.