The Recall Desk
ModerateFDA (Drugs)·D-788-2014·Announced 2014-01-29

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.

What this means for you

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.
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

Distributed in 4 states:

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.

See all 265 products in this recall →

Same manufacturer · Aidapak Services, LLC

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