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.

FDA recall notice · announced April 12, 2017 · Genentech

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: NJ and IL
Lot/code information: B1009MC, B1009M9, B1009MA; Exp. 02/18 B1009MT 02/19
Quantity: 748 bottles
Status: Terminated
Products in this recall event:
- 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. (D-0648-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.