Aidapak Recalls Flecainide Acetate Tablets Due to Label Mixup
Aidapak Services, LLC is recalling Flecaainide Acetate tablets because they may be mislabeled as Colestipol HCL Micronized.
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) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Aidapak Services, LLC is recalling Flecaainide Acetate, Tablet, 100 mg (NDC 00054001125) due to a labeling error. The recall is classified as Class II by the FDA.
The recalled product may be potentially mislabeled as Colestipol HCL Micronized, Tablet, 1 g (NDC 59762045001). The specific pedigree code for the affected Flecaainide Acetate is AD56847_4, and the expiration date is 5/21/2014.
Repacked drugs were distributed in Arizona, California, Oregon, and Washington. Consumers should check their medication labels and contact their healthcare provider or pharmacist if they have questions about this recall.
The recalled product
- Product
- FLECAINIDE ACETATE, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054001125.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- 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)
- FLECAINIDE ACETATE
- Tablet
- 100 mg has the following codes: Pedigree: AD56847_4
- EXP: 5/21/2014.
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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