PlainRecalls
FDA Drug Moderate Class II Terminated

ISOSORBIDE MONONITRATE ER Tablet, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175012837

Reported: January 22, 2014 Initiated: July 2, 2013 #D-671-2014

Product Description

ISOSORBIDE MONONITRATE ER Tablet, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175012837

Reason for Recall

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

Details

Recalling Firm
Aidapak Services, LLC
Units Affected
700 Tablets
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Location
Vancouver, WA

Frequently Asked Questions

What product was recalled?
ISOSORBIDE MONONITRATE ER Tablet, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175012837. Recalled by Aidapak Services, LLC. Units affected: 700 Tablets.
Why was this product 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
Which agency issued this recall?
This recall was issued by the FDA Drug on January 22, 2014. Severity: Moderate. Recall number: D-671-2014.