QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable
Lack of Assurance of Sterility
437 recalls, newest first
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
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
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Labeling: Missing label: the product tube was missing a label and contained a different formulation.
Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal anti-inflammatory drug (NSAID) for the treatment of pain and inflammation.
Lack of assurance of sterility.