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Drug Enforcement D-465-2014

Labeling: Label Mixup; OMEGA-3 FATTY ACID, Capsule, 1000 mg may be potentially mis-labeled as DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: AD33897_16, EXP: 5/9/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD33897_19, EXP: 5/9/2014; PSEUDOEPHEDRINE HCL, Tablet, 60 mg, NDC 00904512559, Pedigree: W002856, EXP: 6/7/2014; DOCUSATE SODIUM, Capsule, 50 mg, N

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description: OMEGA-3 FATTY ACID, Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904404360
Product quantity: 2,799 Capsules
Reason for recall: Labeling: Label Mixup; OMEGA-3 FATTY ACID, Capsule, 1000 mg may be potentially mis-labeled as DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: AD33897_16, EXP: 5/9/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD33897_19, EXP: 5/9/2014; PSEUDOEPHEDRINE HCL, Tablet, 60 mg, NDC 00904512559, Pedigree: W002856, EXP: 6/7/2014; DOCUSATE SODIUM, Capsule, 50 mg, N
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-465-2014
Event ID: 65707
Recall initiation date: July 2, 2013
Center classification date: January 16, 2014
Code info: OMEGA-3 FATTY ACID, Capsule, 1000 mg has the following codes: Pedigree: AD33897_19, EXP: 5/9/2014; Pedigree: AD32328_5, EXP: 5/9/2014; Pedigree: W002852, EXP: 6/7/2014; Pedigree: AD62865_13, EXP: 5/23/2014; Pedigree: W002509, EXP: 6/3/2014; Pedigree: W003705, EXP: 6/25/2014; Pedigree: AD22845_7, EXP: 5/2/2014; Pedigree: AD39588_7, EXP:5/13/2014; Pedigree: AD73627_20, EXP: 5/30/2014; Pedigree: W003870, EXP: 6/27/2014; Pedigree: AD46300_14, EXP: 5/15/2014; Pedigree: AD60211_14, EXP: 5/22/2014; Pedigree: W003052, EXP: 6/12/2014; Pedigree: W003217, EXP: 6/14/2014; Pedigree: AD73623_4, EXP: 5/30/2014; Pedigree: W003462, EXP: 6/20/2014; Pedigree: W003195, EXP: 6/13/2014; Pedigree: W003473, EXP: 6/20/2014.
More code info: —