Drug Enforcement D-722-2014

Labeling:Label Mixup; buPROPion HCl ER (XL), Tablet, 150 mg may be potentially mislabeled as MESALAMINE CR, Capsule, 250 mg, NDC 54092018981, Pedigree: AD52412_1, EXP: 5/17/2014.

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
buPROPion HCl ER (XL), Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 67767014130
Product quantity
60 Tablets
Reason for recall
Labeling:Label Mixup; buPROPion HCl ER (XL), Tablet, 150 mg may be potentially mislabeled as MESALAMINE CR, Capsule, 250 mg, NDC 54092018981, Pedigree: AD52412_1, EXP: 5/17/2014.
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-722-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
buPROPion HCl ER (XL), Tablet, 150 mg has the following code Pedigree: AD52412_4, EXP: 4/30/2014.
More code info