Carbamazepine ER Tablets Recalled for Potential Labeling Error
Aidapak Services is recalling carbamazepine ER tablets that may be mislabeled as acarbose due to a label mixup.
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 error (label mixup) with no reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Aidapak Services, LLC is recalling carbamazepine ER tablets, 200 mg, NDC 51672412401. The recall was initiated because of a label mixup where the product may be potentially mislabeled as acarbose, tablet, 25 mg, NDC 00054014025. The affected lot has the pedigree AD60272_7 and an expiration date of 5/22/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The source text does not report any illnesses or injuries associated with this recall.
Consumers and healthcare providers should check their inventory for carbamazepine ER tablets with the specified NDC and pedigree. If found, they should stop using the product and contact the recalling firm or their supplier for instructions on return or disposal.
The recalled product
- Product
- carBAMazepine ER Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 51672412401
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 200
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)
- carBAMazepine ER
- Tablet
- 200 mg has the following code Pedigree: AD60272_7
- EXP: 5/22/2014.
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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