Class II · Moderate risk
Alprazolam Tablets
CGMP Deviations: Potential risk of Cross Contamination
Mental Health Medication Recalls
Recalls of antidepressants, anti-anxiety and related psychiatric medications.
224 recalls in this category, newest first.
Class II · Moderate risk
Alprazolam Tablets
CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk
Alprazolam Tablets
CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk
BuPROPion Hydrochloride Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Clonazepam Orally Disintegrating Tablets
Failed Tablet/Capsule Specification; oversized tablet found in a bottle
Class III · Low risk
buPROPion Hydrochloride Extended-Release Tablet
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Class III · Low risk
buPROPion Hydrochloride Extended-Release Tablet
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Class II · Moderate risk
Xanax XR (alprazolam)
Failed Dissolution Specifications: low out of specification results for dissolution.
Class II · Moderate risk
alprazolam XR extended-release tablets
Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
Class II · Moderate risk
Alprazolam C-IV 2 mg
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Class II · Moderate risk
Alprazolam C-IV 1 mg 60-count bottles
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Class II · Moderate risk
Alprazolam Tablets
CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.
Class II · Moderate risk
Alprazolam Tablets
CGMP deviations
Class II · Moderate risk
Alprazolam Tablets
cGMP Deviations
Class II · Moderate risk
Alprazolam Tablets
cGMP Deviations
Class II · Moderate risk
Alprazolam Tablets
cGMP Deviations
Class II · Moderate risk
Alprazolam Tablets
cGMP Deviations
Class II · Moderate risk
CITALOPRAM Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Venlafaxine Tablets
Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg
Class II · Moderate risk
bupropion Hydrochloride Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk
Citalopram Oral Solution
Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
Class III · Low risk
Clonazepam Orally Disintegrating Tablets
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
Class III · Low risk
Quetiapine Fumarate Extended-Release Tablets
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Class III · Low risk
Quetiapine Fumarate Extended-Release Tablets
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Class III · Low risk
Quetiapine Fumarate Extended-Release Tablets
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
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