Isosorbide Dinitrate recall: Labeling Error
ISOSORBIDE DINITRATE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781163501.
Why was Isosorbide Dinitrate recalled?
Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: CILOSTAZOL, Tablet, 100 mg, NDC 00054004421, Pedigree: W003470, EXP: 6/20/2014; PERPHENAZINE, Tablet, 8 mg, NDC 00630506221, Pedigree: AD54605_1, EXP: 4/30/2014.
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?
ISOSORBIDE DINITRATE, Tablet, 5 mg has the following codes: Pedigree: W003474, EXP: 6/20/2014; Pedigree: AD56882_1, EXP: 5/21/2014.
- Product
- ISOSORBIDE DINITRATE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781163501.
- Recalling firm
- Aidapak Services, LLC
- Quantity
- 200 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)