Icosapent Ethyl Capsules
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Every FDA drug recall whose status is still Ongoing: the firm is still removing product from the market, or the FDA has not yet closed the file. Some were opened years ago and never formally terminated, so check the initiation date as well as the status.
2,760 recalls, newest first.
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Chemical contamination: Presence of benzene
Chemical contamination: Presence of benzene
Chemical contamination: Presence of benzene
Chemical contamination: Presence of benzene
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Subpotent Drug
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Failed Dissolution Specifications
Failed Tablet/Capsule Specifications