19 FDA recalls mention Temozolomide. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Temozolomide.
Reason Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Reason Failed dissolution specifications
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications
Reason Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
Reason Lack of Processing Controls.
Reason Lack of Processing Controls.
Reason Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Reason Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Reason Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Reason Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing…
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