The Recall Desk
SevereFDA (Drugs)·D-765-2014·Announced 2014-01-29

Aidapak Recalls Atomoxetine Capsules Due to Potential Label Mixup

Aidapak Services is recalling Atomoxetine HCL capsules because they may be mislabeled as other psychiatric medications.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant harm (such as mislabeling psychiatric drugs) are classified as Severe.

Plain-English summary

Aidapak Services, LLC is recalling Atomoxetine HCL capsules, 40 mg, NDC 00002322930. The recall was initiated because the product may be potentially mislabeled as other medications, including Olanzapine tablets and Aripiprazole tablets.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The source text lists specific pedigree codes and expiration dates for the affected lots, including AD21790_82, AD46265_52, AD60272_89, AD73525_67, and W003014.

Consumers should check their medication labels and contact their pharmacist or healthcare provider if they have the affected product. The FDA has classified this as a Class II recall.

The recalled product

Product
ATOMOXETINE HCL, Capsule, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002322930.
Affected units
180

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 (12)

  • ATOMOXETINE HCL
  • Capsule
  • 40 mg has the following codes: Pedigree: AD21790_82
  • EXP: 5/1/2014
  • Pedigree: AD46265_52
  • EXP: 5/15/2014
  • Pedigree: AD60272_89
  • EXP: 5/22/2014
  • Pedigree: AD73525_67
  • EXP: 5/30/2014
  • Pedigree: W003014
  • 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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