# FDA recall D-0003-2022

> **Azurity Pharmaceuticals, Inc.** · Class I · drug recall initiated 2021-08-24.

## 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

- **Recall number:** D-0003-2022
- **Recalling firm:** Azurity Pharmaceuticals, Inc.
- **Classification:** Class I
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-0003-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0003-2022. Source: US FDA. Licensed CC0.

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