OXYBUTYNIN CHLORIDE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603497521.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    OXYBUTYNIN CHLORIDE, Tablet, 5 mg has the following codes: Pedigree: AD52778_61, EXP: 5/20/2014; Pedigree: W003898, EXP: 6/27/2014; Pedigree: AD22616_4, EXP: 5/2/2014.
  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: OXYBUTYNIN CHLORIDE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: FLECAINIDE ACETATE, Tablet, 100 mg, NDC 00054001125, Pedigree: AD56847_4, EXP: 5/21/2014; SODIUM CHLORIDE, Tablet, 1 gm, NDC 00223176001, Pedigree: W003792, EXP: 6/27/2014; VARENICLINE, Tablet, 0.5 mg, NDC 00069046856, Pedigree: AD22616_1, EXP: 5/2/2014.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

OXYBUTYNIN CHLORIDE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603497521.

Product Codes/Lot Numbers:

OXYBUTYNIN CHLORIDE, Tablet, 5 mg has the following codes: Pedigree: AD52778_61, EXP: 5/20/2014; Pedigree: W003898, EXP: 6/27/2014; Pedigree: AD22616_4, EXP: 5/2/2014.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-988-2014

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