The Recall Desk
ModerateFDA (Drugs)·D-623-2014·Announced 2014-01-22

Aidapak Recalls Mislabeled Modafinil Tablets Due to Labeling Error

Aidapak Services, LLC is recalling Modafinil 50 mg tablets that may be mislabeled as Saccharomyces boulardii capsules due to a labeling mixup.

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 mixup, which fits the rubric criteria for minor labeling errors or low-risk contamination.

Plain-English summary

Aidapak Services, LLC is recalling Modafinil tablets, 50 mg (1/2 of 100 mg tablet), prescription only, NDC 55253080130. The recall is due to a labeling mixup where the product may be mislabeled as Saccharomyces boulardii lyo, capsule, 250 mg, NDC 00414200007.

The affected product has the pedigree AD21787_4 and an expiration date of 5/1/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers should check their medication for the specific NDC and pedigree listed above. If the product matches the description, they should contact their pharmacist or healthcare provider for instructions on how to dispose of the medication or obtain a replacement.

The recalled product

Product
MODAFINIL Tablet, 50 mg (1/2 of 100 mg Tablet), Rx only, Distributed by: AidaPak Service, LLC, NDC 55253080130
Affected units
60

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 (3)

  • MODAFINIL Tablet
  • 50 mg (1/2 of 100 mg Tablet) has the following code Pedigree: AD21787_4
  • EXP: 5/1/2014.

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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