Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA…
Reason Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
14 FDA recalls mention Tizanidine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Tizanidine.
Reason Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
Reason Failed Stability Specifications
Reason Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of…
Reason Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Reason Failed Tablet/Capsule Specification: Some tablets are shaved
Reason Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Reason Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Labeling: Label Mixup: tiZANidine HCl, Tablet, 2 mg may have potentially been mislabeled as the following drug: NIACIN TR, Tablet, 500 mg, NDC…
Reason Labeling:Label Mixup; tiZANidine HCL Tablet, 2 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 37205098769, Pedigree…
Reason Labeling:Label Mixup; tiZANidine HCl Tablet, 2 mg may be potentially mislabeled as RIBAVIRIN, Capsule, 200 mg, NDC 68382026007, Pedigree…
Reason Labeling:Label Mixup; tiZANidine HCl Tablet, 1 mg (1/2 of 2 mg) may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00536440801…
Reason Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.
Reason Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.
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