48 FDA recalls mention Niacin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Niacin.
Reason Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at…
Reason Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications
Reason Lack of Processing Controls.
Reason Lack of Processing Controls.
Reason Lack of Processing Controls.
Reason Lack of Processing Controls.
Reason Lack of Processing Controls.
Reason Lack of Processing Controls.
Reason Lack of Processing Controls.
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Reason Presence of Particulate Matter.
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 CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Lack of Assurance of Sterility
Reason Lack of Sterility Assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
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