Ranolazine ER Tablet recall: Labeling Error
RANOLAZINE ER Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 61958100301
Why was Ranolazine ER Tablet recalled?
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:
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- RANOLAZINE ER Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 61958100301
- Recalling firm
- Aidapak Services, LLC
- Quantity
- 840 Tablets
- Distribution
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
- Recall date
- January 22, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)