Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

Dr. Reddy's Laboratories, Inc.

NDC code

55111-180-15

Origin

NJ, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0223-2024

Other Tizanidine recalls

See all

Class II · Moderate risk Ongoing Jun 26, 2023

Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3)…

Reason Failed Stability Specifications

Preferred Pharmaceuticals, Inc. NDC 68788-7781-2 D-0894-2023

Class II · Moderate risk Terminated Jun 23, 2023

Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and…

Reason Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of…

Amerisource Health Services LLC NDC 68084-645-01 D-0892-2023

Class II · Moderate risk Ongoing Jun 21, 2023

Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409…

Reason Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.

Dr Reddy's Laboratories Limited NDC 55111-180-10 D-0923-2023

Class II · Moderate risk Terminated Jul 19, 2021

Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam District, 532…

Reason Failed Tablet/Capsule Specification: Some tablets are shaved

Dr. Reddy's Laboratories, Inc. NDC 55111-180-15 D-0750-2021

Class II · Moderate risk Terminated Nov 24, 2020

Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA…

Reason Failed Dissolution Specifications; Out of Specification (low) results were obtained.

Ascend Laboratories LLC D-0173-2021