The Recall Desk
ModerateFDA (Drugs)·D-986-2014·Announced 2014-01-29

Aidapak Recalls Modafinil Tablets Due to Potential Labeling Mixup

Aidapak Services, LLC is recalling Modafinil 200 mg tablets because they may have been mislabeled as Omega-3-Acid Ethyl Esters capsules.

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 moderate severity involving minor labeling errors or low-risk contamination.

Plain-English summary

Aidapak Services, LLC is recalling Modafinil, Tablet, 200 mg (NDC 00603466216) due to a labeling mixup. The recall involves 60-tablet packages of the prescription medication that may have been incorrectly labeled as Omega-3-Acid Ethyl Esters, Capsule, 1000 mg (NDC 00173078302).

The affected Modafinil tablets have pedigree numbers W002760 (expiration date 6/6/2014) and W003779 (expiration date 6/26/2014). The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers should check their medication for the specific NDC and pedigree numbers listed above. If the product matches the description, they should stop using it and contact their pharmacist or healthcare provider for guidance on returning the medication.

The recalled product

Product
MODAFINIL, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603466216.
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 (6)

  • MODAFINIL
  • Tablet
  • 200 mg has the following codes: Pedigree: W002760
  • EXP: 6/6/2014
  • Pedigree: W003779
  • EXP: 6/26/2014.

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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