Drug product
OMEGA-3 FATTY ACID, Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904404360
D-465-2014
Product summary
- 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
Labeling: Label Mixup