Drug Enforcement D-816-2014

Labeling: Label Mixup: VALSARTAN, Tablet, 160 mg may have potentially been mislabeled as one of the following drugs: PROGESTERONE, Capsule, 100 mg, NDC 00032170801, Pedigree: AD46320_1, EXP: 5/15/2014; CapsuleTOPRIL, Tablet, 6.25 mg (1/2 of 12.5 mg), NDC 00143117101, Pedigree: AD46312_4, EXP: 5/16/2014; MYCOPHENOLATE MOFETIL, Tablet, 500 mg, NDC 00004026001, Pedigree: AD49414_4, EXP: 5/17/2014;

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Status

Terminated

Classification

Class II

Report Date

January 29, 2014

Termination Date

February 7, 2014

Product Information

Product description
VALSARTAN, Tablet, 160 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078035934.
Product quantity
1260 Tablets
Reason for recall
Labeling: Label Mixup: VALSARTAN, Tablet, 160 mg may have potentially been mislabeled as one of the following drugs: PROGESTERONE, Capsule, 100 mg, NDC 00032170801, Pedigree: AD46320_1, EXP: 5/15/2014; CapsuleTOPRIL, Tablet, 6.25 mg (1/2 of 12.5 mg), NDC 00143117101, Pedigree: AD46312_4, EXP: 5/16/2014; MYCOPHENOLATE MOFETIL, Tablet, 500 mg, NDC 00004026001, Pedigree: AD49414_4, EXP: 5/17/2014;
Recall initiation reason
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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
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Codes & Dates

Recall number
D-816-2014
Event ID
65690
Recall initiation date
July 2, 2013
Center classification date
January 20, 2014
Code info
VALSARTAN, Tablet, 160 mg has the following codes: Pedigree: AD39858_1, EXP: 5/16/2014; Pedigree: AD46312_7, EXP: 5/16/2014; Pedigree: AD49414_7, EXP: 5/17/2014; Pedigree: W002767, EXP: 6/6/2014; Pedigree: W003534, EXP: 6/21/2014; Pedigree: W003639, EXP: 6/25/2014; Pedigree: W002851, EXP: 6/7/2014; Pedigree: AD62995_1, EXP: 5/28/2014; Pedigree: W002964, EXP: 6/11/2014.
More code info
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