Recalls of antidepressants, anti-anxiety and related psychiatric medications.
226 recalls in this category, newest first.
Reason CGMP Deviations: Potential risk of Cross Contamination
Reason CGMP Deviations: Potential risk of Cross Contamination
Reason CGMP Deviations: Potential risk of Cross Contamination
Reason Failed Impurities/Degradation Specifications
Reason Failed Tablet/Capsule Specification; oversized tablet found in a bottle
Reason Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be…
Reason Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be…
Reason Failed Dissolution Specifications: low out of specification results for dissolution.
Reason Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
Reason CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Reason CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Reason CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.
Reason CGMP deviations
Reason cGMP Deviations
Reason cGMP Deviations
Reason cGMP Deviations
Reason cGMP Deviations
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Reason Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
Reason Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
Reason Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate…
Reason Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate…
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