Drug Enforcement D-909-2014

Labeling: Label Mixup: FENOFIBRATE, Tablet, 54 mg may have potentially been mislabeled as one of the following drugs: LUBIPROSTONE, Capsule, 24 MCG, NDC 64764024060, Pedigree: AD21790_46, EXP: 5/1/2014; aMILoride HCl, Tablet, 5 mg, NDC 64980015101, Pedigree: AD60272_55, EXP: 5/22/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: W002732, EXP: 6/6/2014.

Status

Terminated

Classification

Class II

Report Date

January 29, 2014

Termination Date

February 7, 2014

Product Information

Product description
FENOFIBRATE, Tablet, 54 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378710077.
Product quantity
270 Tablets
Reason for recall
Labeling: Label Mixup: FENOFIBRATE, Tablet, 54 mg may have potentially been mislabeled as one of the following drugs: LUBIPROSTONE, Capsule, 24 MCG, NDC 64764024060, Pedigree: AD21790_46, EXP: 5/1/2014; aMILoride HCl, Tablet, 5 mg, NDC 64980015101, Pedigree: AD60272_55, EXP: 5/22/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: W002732, EXP: 6/6/2014.
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-909-2014
Event ID
65690
Recall initiation date
July 2, 2013
Center classification date
January 20, 2014
Code info
FENOFIBRATE, Tablet, 54 mg has the following codes: Pedigree: AD21790_52, EXP: 5/1/2014; Pedigree: AD60272_64, EXP: 5/22/2014; Pedigree: W002733, EXP: 6/6/2014.
More code info
—