TIZANIDINE

Generic: TIZANIDINE

Ascend LaboratoriesManufacturer
ORALRoute
TIZANIDINE HYDROCHLORIDEActive Substance
2019-01-25Original Approval

TIZANIDINE is FDA application ANDA211798, sponsored by ALKEM LABS LTD. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2018-09-04
Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited Srilakulam - 532

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

Class II2021-07-19
Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam Distr

Failed Tablet/Capsule Specification: Some tablets are shaved

Class II2023-06-21
Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam -

Failed dissolution specification: Out of specification results observed in 24-month long term stabil

Class III2013-03-19
Tizanidine Tablets USP, 4 mg, 150-count tablets per bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepal

Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the

Class II2020-11-24
Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013,

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

Class II2023-06-26
Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-

Failed Stability Specifications

Class II2024-01-02
Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409

Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.

Class II2023-06-23
Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and D

Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Red

Top Reported Reactions

1
FATIGUE
2,302 reports
2
PAIN
2,088 reports
3
DRUG INEFFECTIVE
2,072 reports
4
NAUSEA
2,071 reports
5
HEADACHE
1,883 reports
6
FALL
1,638 reports
7
DIARRHOEA
1,463 reports
8
DIZZINESS
1,320 reports
9
OFF LABEL USE
1,304 reports
10
CHRONIC KIDNEY DISEASE
1,202 reports