FDA recall D-1191-2018

Dr. Reddy's Laboratories, Inc. · Class II · drug

Product

Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited Srilakulam - 532 409 INDIA, NDC 55111-179-15, UPC 35511179153

Reason for recall

Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .

Distribution

Nationwide within the United States

Key facts

Status
Terminated
Initiation date
2018-09-04
Report date
2018-09-26
Termination date
2022-03-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1191-2018