FDA recall D-1427-2012

Product

Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged and distributed by STAT Rx USA, Gainesville, GA, NDC 16590-221-90.

Reason for recall

Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-07-23

Report date

2012-08-01

Termination date

2013-01-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gainesville, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1427-2012