FDA recall D-0750-2021

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

Product

Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam District, 532 409 INDIA, NDC 55111-180-15.

Reason for recall

Failed Tablet/Capsule Specification: Some tablets are shaved

Distribution

Nationwide within the United States

Key facts

Status
Terminated
Initiation date
2021-07-19
Report date
2021-08-25
Termination date
2022-12-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0750-2021