# FDA recall D-0856-2016

> **Allegiant Health** · Class III · drug recall initiated 2016-02-29.

## Product

col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9; and b) 60-count, item 357392, UPC 0 11822 57392 4; DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL , PA 17011.

## Reason for recall

Superpotent Drug: High out of specification results for assay at the 6 month time point interval.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0856-2016
- **Recalling firm:** Allegiant Health
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-02-29
- **Report date:** 2016-05-25
- **Termination date:** 2018-06-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deer Park, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0856-2016

## Citation

> AI Analytics. FDA recall D-0856-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0856-2016. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
