Recalls / Class III
Class IIID-0416-2018
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
- Affected lot / code info
- Lot # 3141989, EXP 08/31/2019
Why it was recalled
Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.
Recalling firm
- Firm
- Genentech, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Dna Way, South San Francisco, California 94080-4990
Distribution
- Quantity
- 3,192 bottles
- Distribution pattern
- Distributed throughout the United States
Timeline
- Recall initiated
- 2018-02-05
- FDA classified
- 2018-02-13
- Posted by FDA
- 2018-02-21
- Terminated
- 2018-09-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0416-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.