# FDA recall D-0574-2020

> **AuroMedics Pharma LLC** · Class II · drug recall initiated 2019-11-25.

## Product

Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in India for: AuroMedics Pharma LLC, E. Windsor, NJ  08520, NDC 55150-204-20.

## Reason for recall

Discoloration: Product complaints of discoloration after reconstitution of vials.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0574-2020
- **Recalling firm:** AuroMedics Pharma LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-11-25
- **Report date:** 2019-12-18
- **Termination date:** 2021-03-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Windsor, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0574-2020

## Citation

> AI Analytics. FDA recall D-0574-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0574-2020. Source: US FDA. Licensed CC0.

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