The Recall Desk
ModerateFDA (Drugs)·D-680-2014·Announced 2014-01-22

FDA Recalls Mislabelled Eszopiclone Tablets Distributed by Aidapak Services

Aidapak Services is recalling Eszopiclone 3 mg tablets that may be mislabeled as Cholecalciferol 1000 units. The error involves specific pedigree and expiration codes.

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, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling mixup, which is a moderate risk compared to contamination or structural defects.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Eszopiclone, Tablet, 3 mg, distributed by Aidapak Services, LLC. The recall is due to a labeling mixup where the medication may be incorrectly labeled as Cholecalciferol, Tablet, 1000 units.

The affected product is identified by the NDC 63402019310, with a pedigree code of W002765 and an expiration date of 6/6/2014. The mislabeling risk involves the product being confused with Cholecalciferol, Tablet, 1000 units (NDC 00904582460), which has a pedigree code of W002779 and the same expiration date of 6/6/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers and healthcare providers should check their inventory for these specific codes. If the product matches the description, it should be returned to the distributor or a local pharmacy for disposal. Patients should consult their healthcare provider if they have taken the medication and have concerns about the labeling error.

The recalled product

Product
ESZOPICLONE, Tablet, 3 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63402019310
Affected units
100

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)

  • ESZOPICLONE
  • Tablet
  • 3 mg has the following code Pedigree: W002765
  • EXP: 6/6/2014.

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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