778 recalls, newest first
Reason Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Reason Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Reason Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Reason CGMP Deviations
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Reason Presence of Particulate Matter
Reason CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA…
Reason CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Reason CGMP Deviations
Reason cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
Reason Lack of Assurance of Sterility: Media fill with bacterial contamination
Reason Lack of Assurance of Sterility: Media fill with bacterial contamination
Reason Lack of Assurance of Sterility: Media fill with bacterial contamination
Reason Lack of Assurance of Sterility: Media fill with bacterial contamination
Reason Lack of Assurance of Sterility: Media fill with bacterial contamination
Reason Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
Reason Failed dissolution specifications: lower than specifications
Reason LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum…
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations