FDA Drug recall D-0648-2017
Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland
- FDA Drug
- Class II
- terminated
- Published 2017-04-12
On 2017-04-12 the FDA classified a Class II recall of Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland by Genentech, citing superpotent Drug: An oversized tablet was found in a bottle.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0648-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-13 |
| Published | 2017-04-12 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Genentech |
| Distribution | IL, NJ |
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
Superpotent Drug: An oversized tablet was found in a bottle.
Identifiers
| upc | 35024271701 |
|---|---|
| ndc | 50242-717-01 |
| code_info | B1009MC, B1009M9, B1009MA; Exp. 02/18 B1009MT 02/19 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0648-2017%22
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