Agency classClass IIOur severity:Moderate FDA (Drugs)·D-621-2014·Announced 2014-01-22

FDA Recalls Tizanidine Tablets Due to Potential Labeling Mixup

Aidapak Services is recalling Tizanidine HCl tablets because they may be mislabeled as other prescription drugs. The repacked drugs were distributed in four western states.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a moderate severity score. The hazard is a labeling mixup, which is a minor labeling error that could lead to incorrect medication administration but does not involve a high-risk pathogen or immediate structural defect.

Plain-English summary

Aidapak Services, LLC is voluntarily recalling Tizanidine HCl tablets, 2 mg, NDC 55111017915. The recall is due to a labeling mixup where the Tizanidine tablets may be mislabeled as other prescription medications, including Ribavirin, Cyanocobalamin, Niacin, and Pantoprazole Sodium DR.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The specific lot codes and expiration dates for the affected Tizanidine tablets are: Pedigree AD21790_40 (EXP 5/1/2014), Pedigree AD46265_16 (EXP 5/15/2014), Pedigree W002663 (EXP 6/5/2014), and Pedigree AD73525_31 (EXP 5/30/2014).

Consumers and healthcare providers should check their inventory for these specific lot codes and expiration dates. If the product is found, it should be returned to the distributor or the FDA. Patients should consult their healthcare provider if they have questions about their medication.

The recalled product

Product: tiZANidine HCl Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55111017915
Manufacturer: Aidapak Services, LLC
Category: Drug — Prescription Medication
Hazard: mis-labeling
Affected units: 600

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 (10)

tiZANidine HCl
Tablet
2 mg has the following codes Pedigree: AD21790_40
EXP: 5/1/2014
Pedigree: AD46265_16
EXP: 5/15/2014
Pedigree: W002663
EXP: 6/5/2014
Pedigree: AD73525_31
EXP: 5/30/2014.

Distribution

Distributed in 4 states:

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.

See all 273 products in this recall →

Same manufacturer · Aidapak Services, LLC

See all →

Moderate
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Aidapak Recalls Mislabeled Pantoprazole Sodium DR Tablets
FDA (Drugs) · 2014-01-29
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Aidapak Recalls Nifedipine ER Tablets Due to Potential Label Mixup
FDA (Drugs) · 2014-01-29
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Simvastatin Tablets Recalled for Potential Labeling Error
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Same hazard · mis labeling