Aidapak Recalls Flecaïnide Tablets Due to Potential Label Mixup
Aidapak Services is recalling Flecaïnide Acetate tablets that may be mislabeled as Vitamin B Complex with C due to a labeling error.
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 situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a labeling error (mislabeling) rather than a contamination or structural defect.
Plain-English summary
Aidapak Services, LLC is recalling Flecaïnide Acetate Tablets, 50 mg, NDC 65162064110. The recall is due to a potential label mixup where these prescription tablets may be mislabeled as Vitamin B Complex with C Tablets, NDC 00904026013.
The affected product has the pedigree AD46414_16 and an expiration date of 5/16/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers and healthcare providers should check their inventory for this specific NDC and pedigree. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have taken the mislabeled product.
The recalled product
- Product
- FLECAINIDE ACETATE Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162064110
- 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 (3)
- FLECAINIDE ACETATE Tablet
- 50 mg has the following code Pedigree: AD46414_16
- EXP: 5/16/2014.
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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