676 recalls · Class II, newest first
Reason Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Reason Presence of foreign substance: identified as aluminum.
Reason Lack of Assurance of Sterility.
Reason Lack of Assurance of Sterility.
Reason Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Reason Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Reason Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Reason CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Reason CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Reason CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility