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Showing 4661–4680 of 14370 results

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Prasugrel Tablets (Mylan) – Dissolution Failure (2019)

Failed Dissolution Specification: Low out of specification dissolution results.

Class IIModerate

FDAOct 18, 2019Nationwide• Mylan Pharmaceuticals Inc.

Ranitidine 150mg (AVKARE) – NDMA Impurity (2019)

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Class IIModerate

FDAOct 17, 2019CO, MO• AVKARE Inc.

Neomycin Polymyxin Dexamethasone (Sandoz) – Incorrect Labeling (2019)

Labeling: Incorrect or missing package insert.

Class IIILow

FDAOct 17, 2019Nationwide• Sandoz Inc

Gatifloxacin Ophthalmic Solution (Sandoz) – Incorrect Labeling (2019)

Labeling: Incorrect or missing package insert.

FDAOct 17, 2019Nationwide• Sandoz Inc

Bimatoprost Ophthalmic Solution (Sandoz) – Incorrect Labeling (2019)

Labeling: Incorrect or missing package insert.

FDAOct 17, 2019Nationwide• Sandoz Inc

Ranitidine 300mg (AVKARE) – NDMA Impurity (2019)

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Class IIModerate

FDAOct 17, 2019CO, MO• AVKARE Inc.

Isotretinoin Capsules (Amneal) – Impurity Specs (2019)

Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.

FDAOct 16, 2019Nationwide• Amneal Pharmaceuticals, Inc.

Viatrexx-Neuro 3 (Viatrexx) – Sterility Risk (2019)

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Class IIModerate

FDAOct 15, 2019Nationwide• 8046255 Canada Inc. DBA Viatrexx

Viatrexx-Collagen (Viatrexx) – Sterility Risk (2019)

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Class IIModerate

FDAOct 15, 2019Nationwide• 8046255 Canada Inc. DBA Viatrexx

Viatrexx-Ouch (Viatrexx) – Sterility Risk (2019)

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Class IIModerate

FDAOct 15, 2019Nationwide• 8046255 Canada Inc. DBA Viatrexx

Viatrexx-GI (Viatrexx) – Sterility Risk (2019)

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Class IIModerate

FDAOct 15, 2019Nationwide• 8046255 Canada Inc. DBA Viatrexx

Viatrexx-MuSkel-Neural (Viatrexx) – Sterility Risk (2019)

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Class IIModerate

FDAOct 15, 2019Nationwide• 8046255 Canada Inc. DBA Viatrexx

Viatrexx-Infla (Viatrexx) – Sterility Risk (2019)

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Class IIModerate

FDAOct 15, 2019Nationwide• 8046255 Canada Inc. DBA Viatrexx

Viatrexx-Arthros (Viatrexx) – Sterility Risk (2019)

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Class IIModerate

FDAOct 15, 2019Nationwide• 8046255 Canada Inc. DBA Viatrexx

Viatrexx-Relief + (Viatrexx) – Sterility Risk (2019)

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Class IIModerate

FDAOct 15, 2019Nationwide• 8046255 Canada Inc. DBA Viatrexx

Viatrexx-Neuro (Viatrexx) – Sterility Risk (2019)

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Class IIModerate

FDAOct 15, 2019Nationwide• 8046255 Canada Inc. DBA Viatrexx

Viatrexx-Hair (Viatrexx) – Sterility Risk (2019)

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Class IIModerate

FDAOct 15, 2019Nationwide• 8046255 Canada Inc. DBA Viatrexx

Viatrexx-Articula (Viatrexx) – Sterility Risk (2019)

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Class IIModerate

FDAOct 15, 2019Nationwide• 8046255 Canada Inc. DBA Viatrexx

Viatrexx-ANS/CNS (Viatrexx) – Sterility Risk (2019)

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Class IIModerate

FDAOct 15, 2019Nationwide• 8046255 Canada Inc. DBA Viatrexx

Viatrexx-Lymph 1 (Viatrexx) – Sterility Risk (2019)

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Class IIModerate

FDAOct 15, 2019Nationwide• 8046255 Canada Inc. DBA Viatrexx

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