Is Azelaic recalled?
10 FDA recalls mention Azelaic. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Azelaic.
Class II · Moderate risk Ongoing
Reason CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Class II · Moderate risk Ongoing
Reason CGMP Deviations: Market complaints received for gritty texture (grainy)
Class II · Moderate risk Ongoing
Reason CGMP Deviations
Class II · Moderate risk Terminated
Reason cGMP Deviations
Class II · Moderate risk Terminated
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.