RANOLAZINE ER Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 61958100301

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    RANOLAZINE ER, Tablet, 500 mg has the following codes Pedigree: AD23087_1, EXP: 5/2/2014; Pedigree: AD62995_7, EXP: 5/29/2014; Pedigree: W002857, EXP: 6/7/2014; Pedigree: W003538, EXP: 6/21/2014; Pedigree: W003741, EXP: 6/26/2014; Pedigree: AD32757_47, EXP: 5/13/2014; Pedigree: W003648, EXP: 6/25/2014; Pedigree: AD60272_40, EXP: 5/22/2014.
  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; RANOLAZINE ER Tablet, 500 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD25452_16, EXP: 5/3/2014; DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: AD70585_16, EXP: 5/29/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W002852, EXP: 6/7/2014; VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree:
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

RANOLAZINE ER Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 61958100301

Product Codes/Lot Numbers:

RANOLAZINE ER, Tablet, 500 mg has the following codes Pedigree: AD23087_1, EXP: 5/2/2014; Pedigree: AD62995_7, EXP: 5/29/2014; Pedigree: W002857, EXP: 6/7/2014; Pedigree: W003538, EXP: 6/21/2014; Pedigree: W003741, EXP: 6/26/2014; Pedigree: AD32757_47, EXP: 5/13/2014; Pedigree: W003648, EXP: 6/25/2014; Pedigree: AD60272_40, EXP: 5/22/2014.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-667-2014

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