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Methyldopa Tablets (Teva) – Manufacturing Deviation (2014)

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

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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Methyldopa Tablets (Teva) – Manufacturing Deviation (2014)

Paxil Suspension (Apotex) – Chemical Contamination (2014)

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

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

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

Paroxetine HCL Tablets 25mg (Apotex) – Chemical Contamination (2014)

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

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

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

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

ParaGard T 380A Copper IUD (Teva) – Non-Sterile Device (2014)

Risperidone Oral Solution 1mg/mL (Apotex) – Impurity Specification (2014)

Venlafaxine ER Tablets 37.5mg (Caraco) – Dissolution Failure (2014)

Venlafaxine ER Tablets 150mg (Caraco) – Dissolution Failure (2014)

Ranitidine Tablets 150mg (Glenmark) – Foreign Material (2014)

Phosphatidylcholine Injection 50mg/mL (Hollis) – Incorrect Labeling (2014)

Polidocanol 3% Solution (Hollis) – Particulate Matter (2014)

Papaverine Combination Solution (Hollis) – Incorrect Labeling (2014)

Polidocanol 1% Solution (Hollis) – Incorrect Labeling (2014)

Max Kratom (Smiley National) – Unapproved Ingredient (2014)