Drug product
DOCUSATE CALCIUM, Capsule, 240 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536375501.
D-934-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1109 Capsules
- Official record key
drug-enforcement:D-934-2014
Official wording
Reason: Labeling: Label Mixup: DOCUSATE CALCIUM, Capsule, 240 mg may have potentially been mislabeled as one of the following drugs: diphenhydrAMINE HCl, Tablet, 25 mg, NDC 00904555159, Pedigree: AD33897_13, EXP: 5/9/2014; DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071215, Pedigree: AD49610_1, EXP: 5/16/2014; diphenhydrAMINE HCl, Tablet, 25 mg, NDC 00904555159, Pedigree: W002775, EXP: 6/6/2014; VITAMIN B
Code information: DOCUSATE CALCIUM, Capsule, 240 mg has the following codes: Pedigree: AD33897_16, EXP: 5/9/2014; Pedigree: AD49582_16, EXP: 5/16/2014; Pedigree: W002776, EXP: 6/6/2014; Pedigree: W003821, EXP: 6/27/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled