The Recall Desk
ModerateFDA (Drugs)·D-627-2014·Announced 2014-01-22

Aidapak Recalls Tizanidine Tablets Due to Potential Labeling Errors

Aidapak Services, LLC is recalling Tizanidine HCL tablets because they may be mislabeled as Nicotine Polacrilex or Nifedipine ER.

What this means for you

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 typically involves a labeling error that could result in temporary or medically reversible health consequences. The rubric assigns a score of 2 for minor labeling errors or low-risk contamination.

Plain-English summary

Aidapak Services, LLC is recalling Tizanidine HCL Tablets, 2 mg, NDC 57664050289, due to a labeling mixup. The recalled product may be potentially mislabeled as either Nicotine Polacrilex Lozenge, 2 mg, or Nifedipine ER Tablet, 60 mg.

The recall involves specific pedigree codes and expiration dates. Affected Tizanidine units include Pedigree AD70700_10 with an expiration date of 5/29/2014, and Pedigree W003750 with an expiration date of 6/26/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers and healthcare providers should check their inventory for these specific NDC and pedigree codes. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions regarding their medication.

The recalled product

Product
tiZANidine HCL Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664050289
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 (6)

  • tiZANidine HCL
  • Tablet
  • 2 mg has the following codes Pedigree: AD70700_10
  • EXP: 5/29/2014
  • Pedigree: W003750
  • EXP: 6/26/2014.

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

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