Prescription and over-the-counter medications
Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations: products were stored outside the drug label specifications.
Hikma Pharmaceuticals USA
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
Lack of Assurance of Sterility: Complaints received of defective container closure.
Labeling: Label Error on Declared Strength
Glenmark Pharmaceuticals Inc., USA
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations: products were stored outside the drug label specifications.
Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations: products were stored outside the drug label specifications.
Lack of Assurance of Sterility
Hikma Pharmaceuticals USA
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations: products were stored outside the drug label specifications.
Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations: products were stored outside the drug label specifications.
Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations: products were stored outside the drug label specifications.
Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations: products were stored outside the drug label specifications.
Glenmark Pharmaceuticals Inc., USA
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations: products were stored outside the drug label specifications.
Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
Glenmark Pharmaceuticals Inc., USA
Defective Container: Tube split from side seam
Failed Dissolution Specifications: below specification limits for dissolution.
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.