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.
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
Presence of Foreign Substance
Class III · Low risk
BuPROPion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications; 9-monthstability timepoint
Class II · Moderate risk
Alprazolam Tablets
Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.
Class II · Moderate risk
Quetiapine Tablets USP 400 mg
Presence of Foreign Substance; metal shard found in tablet
Class III · Low risk
Contrave (naltrexone HCl and bupropion HCl)
Container packaging defect.
Class II · Moderate risk
Clonazepam Orally Disintegrating Tablets USP
Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.
Class III · Low risk
Bupropion Hydrochloride ER Tablets
Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.
Class III · Low risk
Contrave (naltrexone HCl and bupropion HCl)
Defective Container: Customer complaints of punctures in the bottle.
Class III · Low risk
buPROPion HCl Extended-Release Tablets
Failed Dissolution Specifications; during stability testing
Class III · Low risk
buPROPion HCl Extended-Release Tablets
Failed Dissolution Specifications; during stability testing
Class II · Moderate risk
Duloxetine HCl USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class III · Low risk
Fluoxetine Tablets USP
Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.
Class III · Low risk
Klonopin (clonazepam)
Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.
Class III · Low risk
Duloxetine Delayed-Release Capsules USP
Failed Dissolution Specification
Class II · Moderate risk
Zoloft (sertraline HCl)
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Class II · Moderate risk
Duloxetine Delayed-release Capsules USP
Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Class II · Moderate risk
Alprazolam Tablets
Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Capsules USP
Failed Tablet/Capsules Specifications: pharmacists complaints for bottles containing melted capsules.
Class III · Low risk
BuPROPion HCL Tablets
Failed Moisture Limits: Product tested out-of-specification for moisture content.
Class II · Moderate risk
Venlafaxine Hydrochloride extended release capsules
Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
Class III · Low risk
buPROPion Hydrochloride Extended-release Tablets
Failed Dissolution Specifications; 18 month stability time point
Class III · Low risk
buPROPion Hydrochloride Extended-release Tablets
Failed Dissolution Specifications; 18 month stability time point
Class III · Low risk
BuPROPion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications; 6 month time point
Class III · Low risk
Bupropion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
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