The Recall Desk
ModerateFDA (Drugs)·D-728-2014·Announced 2014-01-22

Fluconazole Tablets Recalled for Potential Labeling Error

Aidapak Services is recalling 50 mg fluconazole tablets that may be mislabeled as 200 mg tablets.

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 (mislabeling) without reported injuries or illnesses, fitting the criteria for moderate severity.

Plain-English summary

Aidapak Services, LLC is recalling specific lots of Fluconazole, Tablet, 50 mg, Rx only, distributed by AidaPak Service, LLC. The recall is due to a labeling error where the 50 mg tablets may be potentially mislabeled as Fluconazole, Tablet, 200 mg.

The affected product is identified by NDC 68462010130, Pedigree W003066, and an expiration date of 6/12/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Patients and healthcare providers should check their medication labels. If the label indicates 200 mg but the product is from the recalled lot, they should contact their pharmacist or healthcare provider for guidance.

The recalled product

Product
FLUCONAZOLE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462010130
Affected units
29

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)

  • FLUCONAZOLE
  • Tablet
  • 50 mg has the following code Pedigree: W003066
  • EXP: 6/12/2014.

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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