# FDA recall D-0023-2017

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2016-07-29.

## Product

Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials).

## Reason for recall

CGMP Deviations

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0023-2017
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-07-29
- **Report date:** 2016-10-19
- **Termination date:** 2018-02-05

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0023-2017

## Citation

> AI Analytics. FDA recall D-0023-2017. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-0023-2017. Source: US FDA. Licensed CC0.

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