The Recall Desk
ModerateFDA (Drugs)·D-681-2014·Announced 2014-01-22

Lurasidone HCl Tablets Recalled for Potential Labeling Mixup

Aidapak Services is recalling Lurasidone HCl 120 mg tablets because they may be mislabeled as Duloxetine HCl DR 20 mg 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. Per the rubric, minor labeling errors and voluntary precautionary recalls are typically rated as Moderate (2).

Plain-English summary

Aidapak Services, LLC is recalling Lurasidone HCl tablets, 120 mg, NDC 63402031230. The recall is due to a labeling mixup where the product may be mislabeled as Duloxetine HCl DR capsules, 20 mg, NDC 00002323560.

The affected Lurasidone HCl tablets have the pedigree W003487 and an expiration date of 6/20/2014. 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 stop using it and contact their pharmacist or healthcare provider for guidance.

The recalled product

Product
LURASIDONE HCL, Tablet, 120 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63402031230
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 (4)

  • LURASIDONE HCL
  • Tablet
  • 120 mg has the following code Pedigree: W003487
  • EXP: 6/20/2014.

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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