February 2018 FDA Recall Drug by Genentech, Inc.
D-0416-2018 - Labeling
This Class III drug recall was voluntarily initiated by Genentech, Inc. on February 5, 2018 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in Distributed throughout the United States and the recall is currently terminated.
Recall Number: D-0416-2018
Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.
02-05-2018
02-21-2018
3,192 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Distributed throughout the United States
09-06-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada, Distributed by Genentech USA, Inc. A Member of the Roach Group, 1 DNA Way South San Francisco, CA 94080-4990. NDC 0004-0068-01
Batch or Lot Expiration Information
Lot# 3141989, EXP 08/31/2019
