Prescription and over-the-counter medications
Central Admixture Pharmacy Services
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Central Admixture Pharmacy Services
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Central Admixture Pharmacy Services
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Central Admixture Pharmacy Services
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Central Admixture Pharmacy Services
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Central Admixture Pharmacy Services
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
CGMP Deviations: Products not manufactured under current good manufacturing practices.
CGMP Deviations
cGMP deviations: Batch was released prior to approval.
CGMP Deviations: Products not manufactured under current good manufacturing practices.
CGMP Deviations: Products not manufactured under current good manufacturing practices.
CGMP Deviations: Products not manufactured under current good manufacturing practices.
CGMP Deviations
CGMP Deviations: Products not manufactured under current good manufacturing practices.
cGMP deviations: Batch was released prior to approval.
CGMP Deviations
Inmar Supply Chain Solutions
CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Also, due to unusually hot weather, FDA Recalled Products may have been subjected to temperatures in excess of storage condition instructions on product labeling.
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
TMC Acquisitions LLC
Lack of Assurance of Sterility