# FDA recall D-1497-2016

> **Teva North America** · Class II · drug recall initiated 2016-06-17.

## Product

Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454  NDC # 0703-7226-01 (20 mL- Multi-dose Vial), NDC # 0703-72263-03 (10 Multi-dose Vials per carton)

## Reason for recall

CGMP Deviations

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1497-2016
- **Recalling firm:** Teva North America
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-06-17
- **Report date:** 2016-09-14
- **Termination date:** 2017-02-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Horsham, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1497-2016

## Citation

> AI Analytics. FDA recall D-1497-2016. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1497-2016. Source: US FDA. Licensed CC0.

---

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