# FDA recall D-0022-2017

> **The Harvard Drug Group** · Class I · drug recall initiated 2016-07-15.

## Product

Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85

## Reason for recall

Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0022-2017
- **Recalling firm:** The Harvard Drug Group
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-07-15
- **Report date:** 2016-10-19
- **Termination date:** 2017-03-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Livonia, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0022-2017

## Citation

> AI Analytics. FDA recall D-0022-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0022-2017. Source: US FDA. Licensed CC0.

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