Lacosamide Oral Solution
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
2,357 recalls · Class II, newest first
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Lack of Assurance of Sterility
Presence of foreign tablets/capsules.
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
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
cGMP deviations
OOS results reported for the Dissolution (by UV) test.
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Defective delivery system