The Recall Desk
HighFDA (Drugs)·D-508-2014·Announced 2014-01-22

Aidapak Recalls Labeled LamoTRIgine Tablets Due to Potential Label Mixup

Aidapak Services is recalling lamoTRIgine tablets that may be mislabeled as oxybutynin chloride or fexofenadine HCL. The error could lead to patients taking the wrong medication.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a label mixup that could result in patients taking the wrong medication, which poses a risk of harm even if specific injuries are not yet reported in the source text.

Plain-English summary

Aidapak Services, LLC is recalling lamoTRIgine, Tablet, 50 mg (1/2 of 100 mg), NDC 136680004701, due to a labeling error. The recalled tablets may be potentially mislabeled as OXYBUTYNIN CHLORIDE, Tablet, 2.5 mg (1/2 of 5 mg), NDC 00603497521, or FEXOFENADINE HCL, Tablet, 60 mg, NDC 45802042578.

The affected lamoTRIgine tablets have the following pedigree and expiration codes: Pedigree ADWA00002116 with an expiration date of 5/31/2014, and Pedigree AD46265_31 with an expiration date of 5/15/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Patients and healthcare providers should check their medication labels and contact their pharmacist or prescriber if they have the affected product. Do not take the medication if the label does not match the prescribed drug.

The recalled product

Product
lamoTRIgine, Tablet, 50 mg (1/2 of 100 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 13668004701
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 (6)

  • lamoTRIgine
  • Tablet
  • 50 mg (1/2 of 100 mg) has the following codes Pedigree: ADWA00002116
  • EXP: 5/31/2014
  • Pedigree: AD46265_31
  • EXP: 5/15/2014.

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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