Drug Enforcement D-815-2014

Labeling: Label Mixup: VALSARTAN, Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: TEMAZEPAM, Capsule, 7.5 mg, NDC 00378311001, Pedigree: AD49418_1, EXP: 5/17/2014; VALSARTAN, Tablet, 320 mg, NDC 00078036034, Pedigree: AD65475_7, EXP: 5/28/2014; ISOSORBIDE MONONITRATE, Tablet, 20 mg, NDC 62175010701, Pedigree: AD67989_10, EXP: 5/28/2014; CHOLECALCIFEROL, Tablet

Status

Terminated

Classification

Class II

Report Date

January 29, 2014

Termination Date

February 7, 2014

Product Information

Product description
VALSARTAN, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078035834.
Product quantity
1440 Tablets
Reason for recall
Labeling: Label Mixup: VALSARTAN, Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: TEMAZEPAM, Capsule, 7.5 mg, NDC 00378311001, Pedigree: AD49418_1, EXP: 5/17/2014; VALSARTAN, Tablet, 320 mg, NDC 00078036034, Pedigree: AD65475_7, EXP: 5/28/2014; ISOSORBIDE MONONITRATE, Tablet, 20 mg, NDC 62175010701, Pedigree: AD67989_10, EXP: 5/28/2014; CHOLECALCIFEROL, Tablet
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-815-2014
Event ID
65690
Recall initiation date
July 2, 2013
Center classification date
January 20, 2014
Code info
VALSARTAN, Tablet, 80 mg has the following codes: Pedigree: AD52372_4, EXP: 5/17/2014; Pedigree: AD65475_10, EXP: 5/28/2014; Pedigree: AD68025_1, EXP: 5/28/2014; Pedigree: AD70585_1, EXP: 5/29/2014; Pedigree: W002768, EXP: 6/10/2014; Pedigree: W003535, EXP: 6/21/2014; Pedigree: AD62995_4, EXP: 5/28/2014; Pedigree: AD73597_1, EXP: 5/31/2014; Pedigree: W002616, EXP: 6/4/2014.
More code info
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