# FDA recall D-1513-2016

> **Sandoz Inc** · Class II · drug recall initiated 2016-08-24.

## Product

Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-008-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ  08540.

## Reason for recall

Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1513-2016
- **Recalling firm:** Sandoz Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-08-24
- **Report date:** 2016-09-28
- **Termination date:** 2017-07-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1513-2016

## Citation

> AI Analytics. FDA recall D-1513-2016. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1513-2016. Source: US FDA. Licensed CC0.

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