D-0416-2018 Class III Terminated
FDA drug recall D-0416-2018 was initiated by Genentech, Inc. on Feb 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 Sep 6, 2018). Affected quantity: 3,192 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 21, 2018
- Initiation Date
- Feb 5, 2018
- Termination Date
- Sep 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0416-2018
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026