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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Psychiatric Medication
- Hazard
- 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
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.
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