norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita…
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
72 FDA recalls mention Norepinephrine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Norepinephrine.
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason cGMP violations
Reason cGMP violations
Reason Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the…
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Reason Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity…
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason CGMP Deviations
Reason Defective container
Reason Defective container
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