FDA recall D-0648-2017

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0648-2017