Aidapak Recalls Mislabeled Carbamazepine ER Capsules
Aidapak Services, LLC is recalling 229 capsules of carbamazepine ER 200 mg due to a labeling mixup where the product may be mislabeled as acamprosate calcium.
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 criteria for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
Aidapak Services, LLC is recalling 229 capsules of carbamazepine ER, 200 mg, NDC 66993040832. The recall is due to a labeling mixup where the product may be potentially mislabeled as acamprosate calcium DR, tablet, 333 mg, NDC 00456333001.
The affected lot has the pedigree AD32764_14 and an expiration date of 5/14/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers should check their medication for the specific NDC and pedigree listed above. If the medication matches the recalled product, they should stop using it and contact their pharmacist or healthcare provider for instructions on how to return the product.
The recalled product
- Product
- carBAMazepine ER, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 66993040832
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 229
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
- Capsule
- 200 mg has the following code Pedigree: AD32764_14
- EXP: 5/14/2014.
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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