D-0648-2017 Class II Terminated
FDA drug recall D-0648-2017 was initiated by Genentech Inc. on March 13, 2017 and is designated Class II. Reason for recall: Superpotent Drug: An oversized tablet was found in a bottle. The recall status is terminated (terminated May 12, 2017). Affected quantity: 748 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 12, 2017
- Initiation Date
- March 13, 2017
- Termination Date
- May 12, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 748 bottles
Product Description
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 Pattern
NJ and IL
Code Information
B1009MC, B1009M9, B1009MA; Exp. 02/18 B1009MT 02/19