Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: tiZANidine HCl, Tablet, 2 mg may have potentially been mislabeled as the following drug: NIACIN TR, Tablet, 500 mg, NDC 00904434260, Pedigree: W002969, EXP: 6/11/2014.
tiZANidine HCl, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378072219.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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
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