Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

Class IIModerate

FDAMar 24, 2014Nationwide• Apotex Inc.

Paxil 40mg (Apotex) – Chemical Contamination (2014)

Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

Class IIModerate

FDAMar 24, 2014Nationwide• Apotex Inc.

Paxil 10mg (Apotex) – Chemical Contamination (2014)

Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

Class IIModerate

FDAMar 24, 2014Nationwide• Apotex Inc.

Indomethacin Capsules 25mg (Teva) – Manufacturing Deviation (2014)

CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements

Class IIModerate

FDAMar 24, 2014Nationwide• Teva Pharmaceuticals USA

Paxil CR 37.5mg (Apotex) – Chemical Contamination (2014)

Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

Class IIModerate

FDAMar 24, 2014Nationwide• Apotex Inc.

Glyburide Metformin Tablets 5/500mg (Teva) – Manufacturing Deviation (2014)

CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements

Class IIModerate

FDAMar 24, 2014Nationwide• Teva Pharmaceuticals USA

Paxil 20mg (Apotex) – Chemical Contamination (2014)

Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

Class IIModerate

FDAMar 24, 2014Nationwide• Apotex Inc.

Paxil CR 25mg (Apotex) – Chemical Contamination (2014)

Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

Class IIModerate

FDAMar 24, 2014Nationwide• Apotex Inc.

Paroxetine HCL Tablets 37.5mg (Apotex) – Chemical Contamination (2014)

Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

Class IIModerate

FDAMar 24, 2014Nationwide• Apotex Inc.

Paroxetine HCL Tablets 12.5mg (Apotex) – Chemical Contamination (2014)

Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

Class IIModerate

FDAMar 24, 2014Nationwide• Apotex Inc.

Methyldopa Tablets (Teva) – Manufacturing Deviation (2014)

CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements

Class IIModerate

FDAMar 24, 2014Nationwide• Teva Pharmaceuticals USA

Paxil Suspension (Apotex) – Chemical Contamination (2014)

Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

Class IIModerate

FDAMar 24, 2014Nationwide• Apotex Inc.

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