FLECAINIDE ACETATE, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054001125.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    FLECAINIDE ACETATE, Tablet, 100 mg has the following codes: Pedigree: AD56847_4, EXP: 5/21/2014.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Aidapak Services, LLC
Reason for Recall:
Labeling: Label Mixup: FLECAINIDE ACETATE, Tablet, 100 mg may be potentially mislabeled as the following drug: COLESTIPOL HCL MICRONIZED, Tablet, 1 g, NDC 59762045001, Pedigree: AD56847_1, EXP: 5/21/2014.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

FLECAINIDE ACETATE, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054001125.

Product Codes/Lot Numbers:

FLECAINIDE ACETATE, Tablet, 100 mg has the following codes: Pedigree: AD56847_4, EXP: 5/21/2014.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-788-2014

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