Drug Enforcement D-817-2014

Labeling: Label Mixup: VALSARTAN, Tablet, 320 mg may have potentially been mislabeled as the following drug: CILOSTAZOL, Tablet, 100 mg, NDC 60505252201, Pedigree: AD65475_4, EXP: 5/28/2014.

Status

Terminated

Classification

Class II

Report Date

January 29, 2014

Termination Date

February 7, 2014

Product Information

Product description
VALSARTAN, Tablet, 320 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078036034.
Product quantity
90 Tablets
Reason for recall
Labeling: Label Mixup: VALSARTAN, Tablet, 320 mg may have potentially been mislabeled as the following drug: CILOSTAZOL, Tablet, 100 mg, NDC 60505252201, Pedigree: AD65475_4, EXP: 5/28/2014.
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-817-2014
Event ID
65690
Recall initiation date
July 2, 2013
Center classification date
January 20, 2014
Code info
VALSARTAN, Tablet, 320 mg has the following codes: Pedigree: AD65475_7, EXP: 5/28/2014.
More code info