D-1451-2014 Class II Terminated
FDA drug recall D-1451-2014 was initiated by Shamrock Medical Solutions Group LLC on Sep 27, 2011 and is designated Class II. Reason for recall: Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg The recall status is terminated (terminated Jul 31, 2014). Affected quantity: 99/240 mg softgel caps.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 30, 2014
- Initiation Date
- Sep 27, 2011
- Termination Date
- Jul 31, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 99/240 mg softgel caps
Product Description
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 Pattern
Product was shipped to the following states: CO, MA, OH, TX & WY.
Code Information
Lot #: 002H79, Use By: 06/19/2013, NDC: 00904-5779-60