Drug product
DOCUSATE SODIUM Capsule, 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 57896040110
D-634-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,998 Capsules
- Official record key
drug-enforcement:D-634-2014
Official wording
Reason: Labeling:Label Mixup; DOCUSATE SODIUM Capsule, 100 mg may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD37063_4, EXP: 5/13/2014; tiZANidine HCl, Tablet, 2 mg, NDC 00378072219, Pedigree: W002975, EXP: 6/11/2014.
Code information: DOCUSATE SODIUM, Capsule, 100 mg has the following codes Pedigree: AD37063_1, EXP: 5/13/2014; Pedigree: W002977, EXP: 6/11/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled