Isosorbide Mononitrate recall: Labeling Error
ISOSORBIDE MONONITRATE, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175010701
Why was Isosorbide Mononitrate recalled?
Labeling:Label Mixup; ISOSORBIDE MONONITRATE Tablet, 20 mg may be potentially mislabeled as COLCHICINE, Tablet, 0.6 mg, NDC 64764011907, Pedigree: AD52778_22, EXP: 5/20/2014; LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: AD67989_7, EXP: 5/28/2014; SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: W002611, EXP: 6/4/2014.
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 MONONITRATE, Tablet, 20 mg has the following codes Pedigree: AD52778_31, EXP: 5/20/2014; Pedigree: AD67989_10, EXP: 5/28/2014; Pedigree: W002656, EXP: 6/4/2014.
- Product
- ISOSORBIDE MONONITRATE, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175010701
- Recalling firm
- Aidapak Services, LLC
- Quantity
- 300 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)