FDA Recalls Tizanidine Tablets Due to Potential Labeling Error
Aidapak Services, LLC is recalling Tizanidine HCl tablets that may be mislabeled as Pyridoxine HCl. The error could lead to patients taking the wrong medication.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The rubric specifies that FDA Class II recalls with potential for significant harm are rated as Severe.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Tizanidine HCl tablets, 1 mg (1/2 of 2 mg), distributed by Aidapak Services, LLC. The recall is due to a labeling mixup where the Tizanidine tablets may be potentially mislabeled as Pyridoxine HCl tablets, 50 mg.
The affected product is identified by NDC 55111-0179-15, with a pedigree code of AD60272_52 and an expiration date of May 22, 2014. The mislabeled product may bear the NDC 00536-4408-01 and pedigree code AD60428_10. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Patients and healthcare providers should check their medication labels to ensure they are taking the correct drug. If you have Tizanidine HCl tablets with the specific pedigree code AD60272_52, you should contact your pharmacist or healthcare provider for guidance on how to proceed. Do not take the medication if you are unsure of its identity.
The recalled product
- Product
- tiZANidine HCl Tablet, 1 mg (1/2 of 2 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 55111017915
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Affected units
- 299
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- tiZANidine HCl
- Tablet
- 1 mg (1/2 of 2 mg) has the following code Pedigree: AD60272_52
- EXP: 5/22/2014.
Distribution
Part of a larger recall action
This product is one of 273 recalled by Aidapak Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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