Drug product
Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to contain Docusate Sodium 240mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Major Pharmaceuticals, Livonia, MI NDC 00904-5779-60
D-1451-2014
Product summary
- Event
- Event 64611
- Status
- Terminated
- Classification
- Class II
- Quantity
- 99/240 mg softgel caps
- Official record key
drug-enforcement:D-1451-2014
Official wording
Reason: Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg
Code information: Lot #: 002H79, Use By: 06/19/2013, NDC: 00904-5779-60
Distribution pattern: Product was shipped to the following states: CO, MA, OH, TX & WY.
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix up