Drug 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.
D-0648-2017
Product summary
- Firm
- Genentech Inc.
- Event
- Event 76726
- Status
- Terminated
- Classification
- Class II
- Quantity
- 748 bottles
- Official record key
drug-enforcement:D-0648-2017
Official wording
Reason: Superpotent Drug: An oversized tablet was found in a bottle.
Code information: B1009MC, B1009M9, B1009MA; Exp. 02/18 B1009MT 02/19
Distribution pattern: NJ and IL
Derived failure modes
-
Potency or specification failure
Superpotent