The Recall Desk
ModerateFDA (Drugs)·D-768-2014·Announced 2014-01-29

Aidapak Recalls Atomoxetine Capsules Due to Potential Label Mixup

Aidapak Services is recalling 80 mg Atomoxetine capsules distributed in four states because they may be mislabeled as other medications.

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 error (mislabeling) without reported illnesses or injuries, fitting the criteria for moderate severity.

Plain-English summary

Aidapak Services, LLC is recalling Atomoxetine HCL capsules, 80 mg, NDC 00002325030, due to a labeling error. The recall was initiated because the product may be potentially mislabeled as other drugs, including Atomoxetine HCL 18 mg, Prenatal Multivitamin/Mineral, or Ranolazine ER 500 mg.

The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. Specific pedigree codes and expiration dates for the recalled units are listed in the official FDA notice.

Consumers who have this product should stop using it and contact their pharmacist or healthcare provider for guidance. The recall is classified as FDA Class II, indicating a reasonable probability of temporary or medically reversible adverse health consequences.

The recalled product

Product
ATOMOXETINE HCL, Capsule, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002325030.
Affected units
120

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 (10)

  • ATOMOXETINE HCL
  • Capsule
  • 80 mg has the following codes: Pedigree: AD30140_19
  • EXP: 5/7/2014
  • Pedigree: W003685
  • EXP: 6/25/2014
  • Pedigree: AD60272_49
  • EXP: 5/22/2014
  • Pedigree: W003003
  • EXP: 6/11/2014.

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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