FDA recall D-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

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

Distributed throughout the United States

Key facts

Status

Terminated

Initiation date

2018-02-05

Report date

2018-02-21

Termination date

2018-09-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

South San Francisco, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0416-2018