FDA recall D-238-2013

Dr. Reddy'S Laboratories · Class III · drug

Product

Tizanidine Tablets USP, 4 mg, 150-count tablets per bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepally - 500 090 India; NDC 55111-180-15.

Reason for recall

Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.

Distribution

Nationwide and Puerto Rico.

Key facts

Status
Terminated
Initiation date
2013-03-19
Report date
2013-04-10
Termination date
2014-02-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-238-2013