Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling:Label Mixup; tiZANidine HCL Tablet, 2 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 37205098769, Pedigree: AD70700_4, EXP: 5/29/2014; NIFEdipine ER, Tablet, 60 mg, NDC 00591319401, Pedigree: W003729, EXP: 6/26/2014.
tiZANidine HCL Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664050289
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
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.