PlainRecalls
FDA Drug Moderate Class II Terminated

ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP Capsule, 65 mg/100 mg/325 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 44183044001

Reported: January 22, 2014 Initiated: July 2, 2013 #D-567-2014

Product Description

ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP Capsule, 65 mg/100 mg/325 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 44183044001

Reason for Recall

Labeling: Label Mixup; ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP Capsule, 65 mg/100 mg/325 mg may be potentially mislabeled as ALBUTEROL SULFATE ER, Tablet, 4 mg, NDC 00378412201, Pedigree: W003578, EXP: 6/24/2014; LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: AD22616_7, EXP: 5/2/2014.

Details

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

Frequently Asked Questions

What product was recalled?
ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP Capsule, 65 mg/100 mg/325 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 44183044001. Recalled by Aidapak Services, LLC. Units affected: 200 Capsules.
Why was this product recalled?
Labeling: Label Mixup; ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP Capsule, 65 mg/100 mg/325 mg may be potentially mislabeled as ALBUTEROL SULFATE ER, Tablet, 4 mg, NDC 00378412201, Pedigree: W003578, EXP: 6/24/2014; LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: AD22616_7, EXP: 5/2/2014.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 22, 2014. Severity: Moderate. Recall number: D-567-2014.