Drug product
SODIUM CHLORIDE, Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00223176001.
D-883-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7891 Tablets
- Official record key
drug-enforcement:D-883-2014
Official wording
Reason: Labeling: Label Mixup: SODIUM CHLORIDE, Tablet, 1 mg may have potentially been mislabeled as one of the following drugs: BISACODYL EC, Tablet, 5 mg, NDC 00904792760, Pedigree: AD34931_1, EXP: 5/9/2014; DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071215, Pedigree: AD70633_1, EXP: 5/29/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W002509, EXP: 6/3/2014; SODIUM CHLORIDE, Tabl
Code information: SODIUM CHLORIDE, Tablet, 1 mg has the following codes: Pedigree: AD39560_1, EXP: 5/13/2014; Pedigree: AD70636_1, EXP: 5/29/2014; Pedigree: AD73662_1, EXP: 6/3/2014; Pedigree: W002611, EXP: 6/4/2014; Pedigree: W003792, EXP: 6/27/2014; Pedigree: AD22845_10, EXP: 5/2/2014; Pedigree: W003115, EXP: 6/13/2014; Pedigree: W003707, EXP: 6/25/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled