Cotellic Tablet, Film Coated
FDA Recall NDC 50242-717
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Cotellic (NDC 50242-717). A significant event, classified as Class II, was initiated on Mar 13, 2017 by Genentech, Inc.. The reported reason for this action was: "Superpotent Drug: An oversized tablet was found in a bottle."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Superpotent Drug: An oversized tablet was found in a bottle.
Mar 13, 2017
Apr 12, 2017
748 bottles
Recall Profile & Regulatory Data
Event ID
76726
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Genentech Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
NJ and IL
Termination Date
May 12, 2017
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.
Batch or Lot Expiration Information
Lot# B1009MC, B1009M9, B1009MA; Exp. 02/18 B1009MT 02/19
Affected Packages Involved in this Recall
50242-717-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
