Aidapak Recalls Dronedarone HCL Tablets Due to Labeling Mixup
Aidapak Services, LLC is recalling Dronedarone HCL 400 mg tablets because they may be mislabeled as Methylergonovine Maleate 0.2 mg.
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 (mislabeling) without reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Aidapak Services, LLC is recalling Dronedarone HCL, Tablet, 400 mg, NDC 00024414260. The recall is due to a labeling mixup where the product may be potentially mislabeled as Methylergonovine Maleate, Tablet, 0.2 mg, NDC 43386014028.
The affected product is identified by Pedigree AD52778_52 and an expiration date of 5/20/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers should check their medication for the specific NDC and pedigree codes listed above. If the product matches the description, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- DRONEDARONE HCL, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00024414260.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 60
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)
- DRONEDARONE HCL
- Tablet
- 400 mg has the following codes: Pedigree: AD52778_52
- EXP: 5/20/2014.
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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