# FDA recall D-1370-2020

> **Aurobindo Pharma USA Inc.** · Class II · drug recall initiated 2020-06-12.

## Product

Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-846-05

## Reason for recall

Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.

## Distribution

U.S.A. Nationwide

## Key facts

- **Recall number:** D-1370-2020
- **Recalling firm:** Aurobindo Pharma USA Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-06-12
- **Report date:** 2020-07-01
- **Termination date:** 2022-12-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Windsor, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1370-2020

## Citation

> AI Analytics. FDA recall D-1370-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1370-2020. Source: US FDA. Licensed CC0.

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