FDA recall D-643-2014

Aidapak Services, LLC · Class II · drug

Product

COLESTIPOL HCL MICRONIZED Tablet, 1 g, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762045001

Reason for recall

Labeling:Label Mixup; COLESTIPOL HCL MICRONIZED Tablet, 1 g may be potentially mislabeled as rifAXIMin, Tablet, 200 mg, NDC 65649030103, Pedigree: AD54587_10, EXP: 4/30/2014.

Distribution

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Key facts

Status: Terminated
Initiation date: 2013-07-02
Report date: 2014-01-22
Termination date: 2014-02-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Vancouver, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-643-2014