# FDA recall D-0859-2016

> **Teva Pharmaceuticals USA** · Class I · drug recall initiated 2016-03-09.

## Product

Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL)  4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03

## Reason for recall

Presence of Particulate Matter:  particulate matter identified as glass in one vial.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0859-2016
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-03-09
- **Report date:** 2016-06-01
- **Termination date:** 2017-02-07

- **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-0859-2016

## Citation

> AI Analytics. FDA recall D-0859-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0859-2016. Source: US FDA. Licensed CC0.

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