# FDA recall D-0001-2019

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2018-09-21.

## Product

Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA  19454, NDC 0093-5416-01  Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with 13 on one side and plain on the other side.

## Reason for recall

Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.

## Distribution

Distributed nationwide in the USA

## Key facts

- **Recall number:** D-0001-2019
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-09-21
- **Report date:** 2018-10-10
- **Termination date:** 2019-05-01

- **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-0001-2019

## Citation

> AI Analytics. FDA recall D-0001-2019. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/D-0001-2019. Source: US FDA. Licensed CC0.

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