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.

Recall Number: D-0003-2022

Firm: Azurity Pharmaceuticals, Inc.

Classification: Class I

Status: Terminated

Report Date: 20211013

Initiation Date: 20210824

Termination Date: 20220512

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

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.