Recalls of antidepressants, anti-anxiety and related psychiatric medications.
226 recalls in this category, newest first.
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…
Reason Presence of Foreign Substance
Reason Failed Dissolution Specifications; 9-monthstability timepoint
Reason Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.
Reason Presence of Foreign Substance; metal shard found in tablet
Reason Container packaging defect.
Reason Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.
Reason Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18…
Reason Defective Container: Customer complaints of punctures in the bottle.
Reason Failed Dissolution Specifications; during stability testing
Reason Failed Dissolution Specifications; during stability testing
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Reason Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of…
Reason Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is…
Reason Failed Dissolution Specification
Reason SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Reason Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Reason Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.
Reason Failed Tablet/Capsules Specifications: pharmacists complaints for bottles containing melted capsules.
Reason Failed Moisture Limits: Product tested out-of-specification for moisture content.
Reason Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
Reason Failed Dissolution Specifications; 18 month stability time point
Reason Failed Dissolution Specifications; 18 month stability time point
Reason Failed Dissolution Specifications; 6 month time point
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