# FDA recall D-0578-2018

> **Teva Pharmaceuticals USA** · Class III · drug recall initiated 2018-02-05.

## Product

Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56

## Reason for recall

Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.

## Distribution

Distributed throughout the United States

## Key facts

- **Recall number:** D-0578-2018
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-02-05
- **Report date:** 2018-02-21
- **Termination date:** 2019-04-30

- **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-0578-2018

## Citation

> AI Analytics. FDA recall D-0578-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0578-2018. Source: US FDA. Licensed CC0.

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