# FDA recall D-0231-2021

> **Genus Lifesciences Inc.** · Class III · drug recall initiated 2020-12-23.

## Product

Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950-354-05 Case NDC: 64950-354-450(40 unit dose cups) Case NDC 64950-354-55 (50 unit dose cups)

## Reason for recall

Presence of Foreign Substance: Particulate matter was found in multiple lots of product.

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0231-2021
- **Recalling firm:** Genus Lifesciences Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-12-23
- **Report date:** 2021-01-20
- **Termination date:** 2021-11-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Allentown, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0231-2021

## Citation

> AI Analytics. FDA recall D-0231-2021. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0231-2021. Source: US FDA. Licensed CC0.

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