# FDA recall D-0657-2016

> **Safecor Health, LLC** · Class II · drug recall initiated 2015-08-13.

## Product

Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box containing 72 cups and one shelf box containing 60 cups, Cherry Brandy Flavor, Rx only, MFG: Roxane; PKG BY Safecor, Woburn, MA; Barcode 0054356605.

## Reason for recall

Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.

## Distribution

NY

## Key facts

- **Recall number:** D-0657-2016
- **Recalling firm:** Safecor Health, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-08-13
- **Report date:** 2016-02-17
- **Termination date:** 2016-02-25

- **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-0657-2016

## Citation

> AI Analytics. FDA recall D-0657-2016. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0657-2016. Source: US FDA. Licensed CC0.

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