PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: August 25, 2021 Initiated: July 19, 2021 #D-0750-2021

Product Description

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

Details

Units Affected
37560 bottles
Distribution
Nationwide within the United States
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 37560 bottles.
Why was this product recalled?
Failed Tablet/Capsule Specification: Some tablets are shaved
Which agency issued this recall?
This recall was issued by the FDA Drug on August 25, 2021. Severity: Moderate. Recall number: D-0750-2021.