Prescription and over-the-counter medications
Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Lack of Assurance of Sterility; media fill failure at manufacturer
Lack of Assurance of Sterility; media fill failure at manufacturer
Lack of Assurance of Sterility; media fill failure at manufacturer
Lack of Assurance of Sterility; media fill failure at manufacturer
Lack of Assurance of Sterility; media fill failure at manufacturer
Lack of Assurance of Sterility; media fill failure at manufacturer
Valeant Pharmaceuticals North America
Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being recalled due to incomplete packaging/labeling. The bottle is missing the product insert and outer carton which contain the complete instruction for use and safety information.
Lack of Assurance of Sterility: Customer complaints for leaking bags.
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. Teva cannot at this time exclude the potential for additional tablets to be below specification.
Organic Herbal Supply
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Organic Herbal Supply
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Lack of Assurance of Sterility: Bags have the potential to leak.
Lack of Assurance of Sterility
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Lack of Assurance of Sterility
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
SCA Pharmaceuticals
Lack of sterility assurance
Lack of Assurance of Sterility: Bags have the potential to leak.