Aidapak Recalls Atomoxetine Capsules Due to Potential Lovastatin Label Mixup
Aidapak Services is recalling Atomoxetine HCL capsules because they may be mislabeled as Lovastatin tablets. The repacked drugs were distributed in four western states.
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, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling mixup between two different prescription drugs, which poses a risk of incorrect medication administration but is not a Class I recall involving death or serious injury.
Plain-English summary
Aidapak Services, LLC is recalling Atomoxetine HCL capsules, 18 mg, NDC 00002323830. The recall is due to a labeling error where the product may be mislabeled as Lovastatin tablets, 20 mg, NDC 00185007201.
The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The specific pedigree code for the recalled Atomoxetine is AD30140_16, with an expiration date of May 7, 2014. The potentially mislabeled Lovastatin product has pedigree code AD28369_1 and the same expiration date.
Consumers and healthcare providers should check their inventory for Atomoxetine HCL capsules with the specified pedigree and expiration date. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions about their medication.
The recalled product
- Product
- ATOMOXETINE HCL, Capsule, 18 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002323830.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- 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)
- ATOMOXETINE HCL
- Capsule
- 18 mg has the following codes: Pedigree: AD30140_16
- EXP: 5/7/2014.
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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