151 FDA recalls mention Choline. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Choline.
Reason Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Reason Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
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: Lack of validation data for sanitization cycles
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 Lack of Assurance of Sterility
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
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 cGMP deviations: Temperature abuse
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
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