Skip to content
Recall Observatory FDA recall evidence

Drug product

OMEGA-3 FATTY ACID, Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904404360

D-465-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
2,799 Capsules
Official record key
drug-enforcement:D-465-2014

Official wording

Reason: 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

Code information: 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.

Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mixup