Class I - Dangerous
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Fagron Compounding Services
Class I - Dangerous
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class I - Dangerous
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class I - Dangerous
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class I - Dangerous
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Incorrect Product Formulation
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper