Fluoxetine Capsules USP, 20 mg recall — FDA D-0971-2015
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the…
Overview of recall records associated with Teva Pharmaceuticals USA, including dates, categories and classifications where available.
Classification mix: Class II: 120, Class III: 23, Class I: 4.
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the…
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the…
Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.
Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due to the potential for superpotent tablets.
Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule…
Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend…
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend…
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend…
Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the…
CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
Presence of Precipitate; precipitation of drug product
This page summarizes recall records in which the official source identifies Teva Pharmaceuticals USA as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.