Prescription and over-the-counter medications
Fusion IV Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Fusion IV Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Fusion IV Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Fusion IV Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Fusion IV Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Fusion IV Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Taro Pharmaceuticals U.S.A.
Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.
Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
NCS Healthcare of Kentucky
Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
American Health Packaging
GMP Deviations: Product bottle may be absent of desiccant.
American Health Packaging
GMP Deviations: Product bottle may be absent of desiccant.
Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.