FDA recall D-0003-2022

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.

Reason for recall

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

Distribution

USA nationwide

Key facts

Status

Terminated

Initiation date

2021-08-24

Report date

2021-10-13

Termination date

2022-05-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wilmington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0003-2022