US Drug Recall Register
Class III · Low risk Terminated Initiated Feb 5, 2018 (9 years ago)

Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

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.

What was recalled

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

Recalling firm
Genentech, Inc.
NDC code
0004-0068-01
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0416-2018

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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