The Recall Desk
ModerateFDA (Drugs)·D-507-2014·Announced 2014-01-22

Aidapak Recalls Paroxetine Tablets Due to Potential Label Mixup

Aidapak Services, LLC is recalling Paroxetine HCl 10 mg tablets because they may be mislabeled as Pantoprazole Sodium DR 20 mg.

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 significant error but does not involve a direct physical defect or reported serious injury in the source text.

Plain-English summary

Aidapak Services, LLC is recalling Paroxetine HCl, Tablet, 10 mg, NDC 13107015430. The recall is due to a labeling error where the product may be mislabeled as Pantoprazole Sodium DR, Tablet, 20 mg, NDC 62175018046.

The affected Paroxetine HCl tablets have the pedigree AD52778_67 and an expiration date of 5/20/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers and healthcare providers should check their inventory for this specific product and stop using it if the label is incorrect. They should contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
PARoxetine HCl, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 13107015430
Affected units
30

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)

  • PARoxetine HCl
  • Tablet
  • 10 mg has the following code Pedigree: AD52778_67
  • EXP: 5/20/2014.

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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