Drug product
DOCUSATE SODIUM, Capsule, 250 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904789159
D-491-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,318 Capsules
- Official record key
drug-enforcement:D-491-2014
Official wording
Reason: Labeling: Label Mixup; DOCUSATE SODIUM, Capsule, 250 mg may be potentially mislabeled as ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg, NDC 00378041501, Pedigree: AD65475_13, EXP: 5/28/2014; VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD68025_1, EXP: 5/28/2014; PANTOPRAZOLE SODIUM DR, Tablet, 40 mg, NDC 64679043402, Pedigree: AD37063_10, EXP: 5/13/2014; DOCUSATE SODIUM
Code information: DOCUSATE SODIUM, Capsule, 250 mg has the following codes Pedigree: AD68028_1, EXP: 5/28/2014; Pedigree: AD68022_1, EXP: 5/28/2014; Pedigree: AD37072_1, EXP: 5/13/2014; Pedigree: AD37072_4, EXP: 5/13/2014; Pedigree: AD56924_1, EXP: 5/21/2014; Pedigree: W003671, EXP: 6/25/2014; Pedigree: W002920, EXP: 6/10/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled