# FDA recall D-0609-2020

> **AuroMedics Pharma LLC** · Class II · drug recall initiated 2019-11-12.

## Product

Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for: AuroMedics Pharma, LLC, E. Windsor, NJ

## Reason for recall

Discoloration; Hazy solution found in one vial instead of a clear solution.

## Distribution

Product was distributed to major wholesalers/distributors who may have further distribute the product throughout the United States.

## Key facts

- **Recall number:** D-0609-2020
- **Recalling firm:** AuroMedics Pharma LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-11-12
- **Report date:** 2019-12-11
- **Termination date:** 2021-01-21

- **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-0609-2020

## Citation

> AI Analytics. FDA recall D-0609-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0609-2020. Source: US FDA. Licensed CC0.

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