411 recalls · Class II, newest first
Reason Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Reason CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Reason CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Reason CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Reason Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Reason CGMP Deviations; product intended for quarantine was inadvertently distributed
Reason Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Reason Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Reason Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term…
Reason Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Reason Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Reason Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Reason CGMP Deviations
Reason Failed Dissolution Specifications:
Reason Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Reason Presence of Foreign Tablets/Capsules
Reason CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Reason CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Reason CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Reason CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Reason Crystallization
Reason Crystallization
Reason Lack of Sterility Assurance
Reason Lack of Sterility Assurance
Reason CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.