Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to contain Docusate Sodium 2...
FDA Recall #D-1451-2014 — Class II — September 27, 2011
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
Recalling Firm
Shamrock Medical Solutions Group LLC — Lewis Center, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
99/240 mg softgel caps
Distribution
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated