March 2017 FDA Recall Cotellic by Genentech Inc.
D-0648-2017 - Superpotent Drug
This Class II drug recall was voluntarily initiated by Genentech Inc. on March 13, 2017 for the product Cotellic. The FDA reported the reason for recall as superpotent drug. The product was distributed in NJ and IL and the recall is currently terminated.
Recall Number: D-0648-2017
Superpotent Drug: An oversized tablet was found in a bottle.
03-13-2017
04-12-2017
748 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Genentech Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
NJ and IL
05-12-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of 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.
Batch or Lot Expiration Information
Lot# B1009MC, B1009M9, B1009MA; Exp. 02/18 B1009MT 02/19
