Prescription and over-the-counter medications
Breckenridge Pharmaceutical
Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
Cross Contamination with Other Products
Silver Star Brands
Microbial Contamination of Non-Sterile Products
Lack of Assurance of Sterility
Lack of Assurance of Sterility
S.C. Johnson Professional
CGMP Deviations: Product was released to market prior to microbiological testing.
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Lack of Assurance of Sterility
Lack of Assurance of Sterility; bags have the potential to leak
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility; bags have the potential to leak
Lack of Assurance of Sterility
Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
Lack of Assurance of Sterility
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Silver Star Brands
Microbial Contamination of Non-Sterile Products
Lack of Assurance of Sterility
Silver Star Brands
Microbial Contamination of Non-Sterile Product
Lack of Assurance of Sterility