The Recall Desk
ModerateFDA (Drugs)·D-868-2014·Announced 2014-01-29

Aidapak Recalls Repaglinide Tablets Due to Potential Label Mixup

Aidapak Services is recalling Repaglinide 1 mg tablets because they may have been mislabeled as Valsartan, Guaifenesin, or Magnesium Chloride.

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 and involves a labeling error (label mixup) without reported illnesses or injuries, which aligns with the rubric criteria for moderate severity.

Plain-English summary

Aidapak Services, LLC is recalling Repaglinide 1 mg tablets (NDC 00169008281) due to a potential label mixup. The recalled Repaglinide tablets may have been mislabeled as Valsartan 40 mg, Guaifenesin 200 mg, or Magnesium Chloride 64 mg.

The affected Repaglinide tablets have the following pedigree and expiration codes: Pedigree AD52387_1 (EXP 5/17/2014), Pedigree W002855 (EXP 6/7/2014), and Pedigree W003924 (EXP 6/28/2014). 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 Repaglinide tablets. The FDA classifies this recall as Class II, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
REPAGLINIDE, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00169008281.
Affected units
500

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 (8)

  • REPAGLINIDE
  • Tablet
  • 1 mg has the following codes: Pedigree: AD52387_1
  • EXP: 5/17/2014
  • Pedigree: W002855
  • EXP: 6/7/2014
  • Pedigree: W003924
  • EXP: 6/28/2014.

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 265 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 265 products in this recall →

Same manufacturer · Aidapak Services, LLC

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