# FDA recall D-0416-2018

> **Genentech, Inc.** · Class III · drug recall initiated 2018-02-05.

## Product

Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada, Distributed by Genentech USA, Inc. A Member of the Roach Group, 1 DNA Way South San Francisco, CA 94080-4990. NDC 0004-0068-01

## Reason for recall

Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted  from the product carton, primary label is correct.

## Distribution

Distributed throughout the United States

## Key facts

- **Recall number:** D-0416-2018
- **Recalling firm:** Genentech, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-02-05
- **Report date:** 2018-02-21
- **Termination date:** 2018-09-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South San Francisco, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0416-2018

## Citation

> AI Analytics. FDA recall D-0416-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-0416-2018. Source: US FDA. Licensed CC0.

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