# FDA recall D-1494-2016

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

## Product

ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-0020-31 (Single Use Bag), NDC # 0703-0020-32 (5 Single Use Bags in One Carton).

## Reason for recall

CGMP Deviations

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1494-2016
- **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-1494-2016

## Citation

> AI Analytics. FDA recall D-1494-2016. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1494-2016. Source: US FDA. Licensed CC0.

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