PlainRecalls
FDA Drug Moderate Class II Terminated

RALOXIFENE HCL, Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002416530.

Reported: January 29, 2014 Initiated: July 2, 2013 #D-769-2014

Product Description

RALOXIFENE HCL, Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002416530.

Reason for Recall

Labeling: Label Mixup: RALOXIFENE HCL, Tablet, 60 mg may be potentially mis-labeled as following drug: ISOSORBIDE MONONITRATE, Tablet, 20 mg, NDC 62175010701; Pedigree: W002656, EXP: 6/4/2014.

Details

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

Frequently Asked Questions

What product was recalled?
RALOXIFENE HCL, Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002416530.. Recalled by Aidapak Services, LLC. Units affected: 30 Tablets.
Why was this product recalled?
Labeling: Label Mixup: RALOXIFENE HCL, Tablet, 60 mg may be potentially mis-labeled as following drug: ISOSORBIDE MONONITRATE, Tablet, 20 mg, NDC 62175010701; Pedigree: W002656, EXP: 6/4/2014.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 29, 2014. Severity: Moderate. Recall number: D-769-2014.