Drug Enforcement D-643-2014

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.

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
COLESTIPOL HCL MICRONIZED Tablet, 1 g, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762045001
Product quantity
120 Tablets
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.
Recall initiation reason
Initial firm notification
Telephone
Distribution pattern
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Location & Firm

Recalling firm
Aidapak Services, LLC
Address
14301 Se 1st St

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-643-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
COLESTIPOL HCL MICRONIZED, Tablet, 1 g has the following code Pedigree: AD56847_1, EXP: 5/21/2014.
More code info