Drug product
OMEGA-3 FATTY ACID Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 40985022921
D-553-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36,840 Capsules
- Official record key
drug-enforcement:D-553-2014
Official wording
Reason: Labeling: Label Mixup; OMEGA-3 FATTY ACID Capsule, 1000 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060, Pedigree: AD22865_19, EXP: 5/2/2014; CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: AD30028_7, EXP: 5/8/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: W003054, EXP: 6/12/2014; CHOLECALCIFEROL, Capsule, 2000 units, ND
Code information: OMEGA-3 FATTY ACID Capsule, 1000 mg has the following codes Pedigree: AD21846_1, EXP: 5/1/2014; Pedigree: AD30028_4, EXP: 5/8/2014; Pedigree: W003015, EXP: 6/12/2014; Pedigree: W003710, EXP: 6/26/2014; Pedigree: W003711, EXP: 6/26/2014; Pedigree: AD46257_1, EXP: 5/15/2014; Pedigree: W002965, EXP: 6/10/2014; Pedigree: W003312, EXP: 6/18/2014; Pedigree: AD30028_1, EXP: 5/8/2014; Pedigree: AD46257_4, EXP: 5/15/2014; Pedigree: AD32742_1, EXP: 5/1/2014; Pedigree: AD60240_1, EXP: 5/22/2014; Pedigree: ADWA00002135, EXP: 5/31/2014; Pedigree: W002690, EXP: 6/5/2014; Pedigree: W003313, EXP: 6/18/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled