Recalls of antidepressants, anti-anxiety and related psychiatric medications.
226 recalls in this category, newest first.
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the…
Reason Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Reason Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Reason Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Reason Presence of Foreign Tablets/Capsules
Reason CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications
Reason CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Reason CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Reason CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Reason CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Reason CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Reason CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Reason CGMP Deviations: Potential risk of Cross Contamination
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.