56 FDA recalls mention Benzyl. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Benzyl.
Reason Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly…
Reason Sub Potent
Reason Sub Potent
Reason Super Potent
Reason Sub Potent
Reason Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Reason Lack of sterility assurance.
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Reason Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Reason Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Reason Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Reason Lack of Processing Controls: The metal container closure adheres to the rubber stopper on some of the units of the batch which can impact the…
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
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
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