# FDA recall D-1445-2020

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class III · drug recall initiated 2020-07-06.

## Product

Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86

## Reason for recall

Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-1445-2020
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-07-06
- **Report date:** 2020-08-05
- **Termination date:** 2023-06-08

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1445-2020

## Citation

> AI Analytics. FDA recall D-1445-2020. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/D-1445-2020. Source: US FDA. Licensed CC0.

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