Drug product
DOCUSATE SODIUM, Capsule, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 67618010060
D-721-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 181 Capsules
- Official record key
drug-enforcement:D-721-2014
Official wording
Reason: Labeling:Label Mixup; DOCUSATE SODIUM, Capsule, 50 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101, Pedigree: AD60211_1, EXP: 5/21/2014; MEXILETINE HCL, Capsule, 150 mg, NDC 00093873901, Pedigree: AD62865_7, EXP: 5/23/2014; CHOLECALCIFEROL, Tablet, 5000 units, NDC 00761017840, Pedigree: AD65457_10, EXP: 5/24/2014.
Code information: DOCUSATE SODIUM, Capsule, 50 mg has the following codes Pedigree: AD60211_8, EXP: 5/21/2014; Pedigree: AD62865_10, EXP: 5/23/2014; Pedigree: AD65457_13, EXP: 5/24/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled