D-0416-2018 Class III Terminated
FDA drug recall D-0416-2018 was initiated by Genentech, Inc. on February 5, 2018 and is designated Class III. Reason for recall: Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct. The recall status is terminated (terminated September 6, 2018). Affected quantity: 3,192 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 21, 2018
- Initiation Date
- February 5, 2018
- Termination Date
- September 6, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,192 bottles
Product Description
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
Reason for Recall
Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.
Distribution Pattern
Distributed throughout the United States
Code Information
Lot # 3141989, EXP 08/31/2019