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Recall Observatory FDA recall evidence

Drug 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

D-0416-2018

February 05, 2018

Class III

Product summary

Firm
Genentech, Inc.
Event
Event 79175
Status
Terminated
Classification
Class III
Quantity
3,192 bottles
Official record key
drug-enforcement:D-0416-2018

Official wording

Reason: Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.

Code information: Lot # 3141989, EXP 08/31/2019

Distribution pattern: Distributed throughout the United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.