# FDA recall D-116-2013

> **New England Compounding Center** · Class II · drug recall initiated 2012-09-26.

## Product

Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, Framingham, MA

## Reason for recall

Lack of Assurance of Sterility

## Distribution

Nationwide

## Key facts

- **Recall number:** D-116-2013
- **Recalling firm:** New England Compounding Center
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-09-26
- **Report date:** 2013-01-09
- **Termination date:** 2016-10-07

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-116-2013

## Citation

> AI Analytics. FDA recall D-116-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-116-2013. Source: US FDA. Licensed CC0.

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