Aidapak Recalls OXcarbazepine Tablets Due to Potential Labeling Error
Aidapak Services, LLC is recalling OXcarbazepine 600 mg tablets that may be mislabeled as Lactase Enzyme 3000 units. 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 typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling mixup, which is a significant error but does not involve a direct physical defect or contamination.
Plain-English summary
Aidapak Services, LLC is recalling OXcarbazepine Tablet, 600 mg, Rx only, NDC 62756018588. The recall is due to a labeling mixup where the product may be mislabeled as LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976. The affected product has the pedigree AD30140_46 and an expiration date of 5/7/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This labeling error poses a risk because patients or healthcare providers might dispense or administer the wrong medication, potentially leading to ineffective treatment or adverse health effects.
Consumers and healthcare providers should check their inventory for OXcarbazepine 600 mg tablets with the specified pedigree and expiration date. If found, they should stop using the product and contact Aidapak Services, LLC for instructions on return or disposal.
The recalled product
- Product
- OXcarbazepine Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62756018588
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Anticonvulsant
- Hazard
- Affected units
- 100
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)
- OXcarbazepine
- Tablet
- 600 mg has the following code Pedigree: AD30140_46
- EXP: 5/7/2014.
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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