Isosorbide Mononitrate ER Tablet recall: Labeling Error
ISOSORBIDE MONONITRATE ER Tablet, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175012837
Why was Isosorbide Mononitrate ER Tablet recalled?
Labeling:Label Mixup; ISOSORBIDE MONONITRATE ER Tablet, 30 mg may be potentially mislabeled as LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: W003899, EXP: 6/27/2014; MISOPROSTOL, Tablet, 100 mcg, NDC 43386016012, Pedigree: AD42611_7, EXP: 5/14/2014; hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: W003332, EXP: 6/18/2014; glyBURIDE, Tablet, 2.5 mg, NDC 0009383
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 ER Tablet, 30 mg has the following codes Pedigree: W003996, EXP: 7/1/2014; Pedigree: AD46297_1, EXP: 5/15/2014; Pedigree: W003350, EXP: 6/18/2014; Pedigree: AD21790_64, EXP: 5/1/2014; Pedigree: AD32757_37, EXP: 5/14/2014.
- Product
- ISOSORBIDE MONONITRATE ER Tablet, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175012837
- Recalling firm
- Aidapak Services, LLC
- Quantity
- 700 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)