323 FDA recalls mention Phenyl. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Phenyl.
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 CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Reason Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
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 Product mix-up: incorrect product was found inside the G-Supress DX product carton.
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 CGMP DEVIATIONS
Reason CGMP DEVIATIONS
Reason CGMP DEVIATIONS
Reason CGMP DEVIATIONS
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Reason Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the…
Reason Lack of Assurance of Sterility
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