# FDA recall D-0648-2017

> **Genentech Inc.** · Class II · drug recall initiated 2017-03-13.

## Product

Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland. Distributed by Genentech USA, Inc., South Francisco, CA. 94080, NDC 50242-717-01,UPC 3 50242-717-01.

## Reason for recall

Superpotent Drug: An oversized tablet was found in a bottle.

## Distribution

NJ and IL

## Key facts

- **Recall number:** D-0648-2017
- **Recalling firm:** Genentech Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-03-13
- **Report date:** 2017-04-12
- **Termination date:** 2017-05-12

- **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-0648-2017

## Citation

> AI Analytics. FDA recall D-0648-2017. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0648-2017. Source: US FDA. Licensed CC0.

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