FDA recall D-1451-2014

Shamrock Medical Solutions Group LLC · Class II · 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

Reason for recall

Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg

Distribution

Product was shipped to the following states: CO, MA, OH, TX & WY.

Key facts

Status: Terminated
Initiation date: 2011-09-27
Report date: 2014-07-30
Termination date: 2014-07-31
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lewis Center, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1451-2014