# FDA recall D-0868-2016

> **Teva North America** · Class II · drug recall initiated 2016-04-27.

## Product

Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use Container bags per Box Pack (NDC 0703-9060-33), Rx only, Manufactured In Hungary By: Teva Pharmaceutical Works Ltd., Hungary, H-2100 Godollo, Tancsics M. ut 82 Hungary; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454

## Reason for recall

Lack of Assurance of Sterility:  Due to potential for leaking bags.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0868-2016
- **Recalling firm:** Teva North America
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-04-27
- **Report date:** 2016-06-01
- **Termination date:** 2018-02-05

- **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-0868-2016

## Citation

> AI Analytics. FDA recall D-0868-2016. Retrieved 2026-05-31 from https://api.ai-analytics.org/recall/D-0868-2016. Source: US FDA. Licensed CC0.

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