Aripiprazole Tablets Recalled Due to Potential Labeling Errors
Aidapak Services, LLC is recalling Aripiprazole 15 mg tablets because they may be mislabeled as Atomoxetine or Pramipexole.
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 2/5 (Moderate).
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, which fits the rubric for minor labeling errors or low-risk contamination.
Plain-English summary
Aidapak Services, LLC is recalling Aripiprazole Tablet, 15 mg, Rx only, NDC 59148000913. The recall is due to a labeling mixup where the product may be potentially mislabeled as ATOMOXETINE HCL, Capsule, 40 mg, or PRAMIPEXOLE DI-HCL, Tablet, 0.125 mg.
The affected Aripiprazole tablets have the following codes: Pedigree AD21965_1 with an expiration date of 5/1/2014, and Pedigree AD28322_1 with an expiration date of 5/6/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Patients and healthcare providers should verify the labeling of their medications. If the product matches the description and codes listed above, it should be returned to the pharmacy or recalled firm for replacement or refund.
The recalled product
- Product
- ARIPiprazole Tablet, 15 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59148000913
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 150
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 (5)
- ARIPiprazole Tablet
- 15 mg has the following codes Pedigree: AD21965_1
- EXP: 5/1/2014
- Pedigree: AD28322_1
- EXP: 5/6/2014.
Distribution
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.
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