# FDA recall D-0465-2017

> **VistaPharm, Inc.** · Class II · drug recall initiated 2017-01-18.

## Product

Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12 bottles per case (NDC No. 66689-695-30), b). 1 liter (1000 mL), 4 bottles per case, (NDC No. 66689-695-79),  Rx only, Manufactured by VistaPharm, Largo, FL 33771.

## Reason for recall

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0465-2017
- **Recalling firm:** VistaPharm, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-01-18
- **Report date:** 2017-02-08
- **Termination date:** 2021-08-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Largo, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0465-2017

## Citation

> AI Analytics. FDA recall D-0465-2017. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0465-2017. Source: US FDA. Licensed CC0.

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