Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, total volume = 1047 mL, EVA Bag, Rx only, Central…
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
774 recalls, newest first
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Failed Impurities/Degradation Specifications
Reason Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Reason Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled…
Reason Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Reason Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Reason Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Reason Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons labeled as hello wild strawberry fluoride toothpaste were…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
Reason Failed dissolution specifications - results obtained were below spec average.
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
Reason cGMP deviations: Batch was released prior to approval.
Reason cGMP deviations: Batch was released prior to approval.
Reason cGMP deviations: due to shipment of rejected units.