# FDA recall D-0785-2016

> **Safecor Health, LLC** · Class II · drug recall initiated 2015-07-16.

## Product

Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg  DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only, MFG: Concordia, PKG BY: SAFECOR HEALTH, WOBURN, MA, C5921242304.

## Reason for recall

Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.

## Distribution

NY

## Key facts

- **Recall number:** D-0785-2016
- **Recalling firm:** Safecor Health, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-07-16
- **Report date:** 2016-04-06
- **Termination date:** 2016-03-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Woburn, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0785-2016

## Citation

> AI Analytics. FDA recall D-0785-2016. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0785-2016. Source: US FDA. Licensed CC0.

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