Aidapak Recalls Itraconazole Capsules Due to Potential Labeling Error
Aidapak Services, LLC is recalling Itraconazole capsules because they may be mislabeled as Famciclovir tablets. The error could lead to patients receiving the wrong medication.
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 involves a labeling error that could lead to temporary or medically reversible health consequences. No specific injuries or illnesses are reported in the source text, fitting the Moderate severity criteria for minor labeling errors.
Plain-English summary
Aidapak Services, LLC is recalling Itraconazole, Capsule, 100 mg, NDC 10147170003, distributed in Arizona, California, Oregon, and Washington. The recall is due to a labeling error where the product may be mislabeled as Famciclovir, Tablet, 500 mg, NDC 00093811956.
The affected product has the pedigree AD54549_10 and an expiration date of 5/20/2014. The mislabeled product has the pedigree AD54549_4 and the same expiration date. This labeling mixup poses a risk that patients may receive the wrong medication, potentially leading to ineffective treatment or adverse health effects.
Healthcare providers and patients should check their inventory and prescriptions for this specific NDC and pedigree. If the product is found, it should be returned to the distributor or pharmacy for replacement or refund. Consumers should consult their healthcare provider if they have received or taken the affected medication.
The recalled product
- Product
- ITRACONAZOLE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 10147170003
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Antifungal
- 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)
- ITRACONAZOLE
- Capsule
- 100 mg has the following code Pedigree: AD54549_10
- EXP: 5/20/2014.
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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