Dronedarone HCL recall: Labeling Error
DRONEDARONE HCL, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00024414260.
Why was Dronedarone HCL recalled?
Labeling: Label Mixup: DRONEDARONE HCL, Tablet, 400 mg may be potentially as the following drug: METHYLERGONOVINE MALEATE, Tablet, 0.2 mg, NDC 43386014028, Pedigree: AD52778_40, EXP: 5/20/2014.
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?
DRONEDARONE HCL, Tablet, 400 mg has the following codes: Pedigree: AD52778_52, EXP: 5/20/2014.
- Product
- DRONEDARONE HCL, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00024414260.
- Recalling firm
- Aidapak Services, LLC
- Quantity
- 60 Tablets
- Distribution
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
- Recall date
- January 29, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)