Recalls / Class II
Class IID-1451-2014
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
- Affected lot / code info
- Lot #: 002H79, Use By: 06/19/2013, NDC: 00904-5779-60
Why it was recalled
Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg
Recalling firm
- Firm
- Shamrock Medical Solutions Group LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 741 Radio Dr, Lewis Center, Ohio 43035-7134
Distribution
- Quantity
- 99/240 mg softgel caps
- Distribution pattern
- Product was shipped to the following states: CO, MA, OH, TX & WY.
Timeline
- Recall initiated
- 2011-09-27
- FDA classified
- 2014-07-23
- Posted by FDA
- 2014-07-30
- Terminated
- 2014-07-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1451-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.