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Showing 4681–4700 of 14370 results

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Viatrexx-Male+ (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-Intra-Cell (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-Ithurts (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-Facial (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-Immunexx (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-Systemic Detox (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-Adipose (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-Connectissue (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-Prolo (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-Mesenchyme (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

Natural Grocers Organic Soybeans (Natural Grocers) – mold potential (2019)

Firm is recalling two lots of 2 lb. organic soybeans because they have the potential to contain mold.

FDAOct 14, 2019Nationwide• Vitamin Cottage Natural Foods Market, Inc DBA Natural Grocers

Levetiracetam Injection (X-Gen) – Incorrect Labeling (2019)

Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.

FDAOct 11, 2019Nationwide• X-Gen Pharmaceuticals Inc.

Chorionic Gonadotropin 11,000 Units (Innoveix) – Sterility Risk (2019)

Lack of Sterility Assurance.

Class IIModerate

FDAOct 10, 2019Nationwide• Innoveix Pharmaceuticals Inc

Human Chorionic Gonadotropin 5,500 Units (Innoveix) – Sterility Risk (2019)

Lack of Sterility Assurance.

Class IIModerate

FDAOct 10, 2019Nationwide• Innoveix Pharmaceuticals Inc

Sermorelin w/ GHRP2 (Innoveix) – Sterility Risk (2019)

Lack of Sterility Assurance.

Class IIModerate

FDAOct 10, 2019Nationwide• Innoveix Pharmaceuticals Inc

Human Chorionic Gonadotropin 5,000 Units (Innoveix) – Sterility Risk (2019)

Lack of Sterility Assurance.

Class IIModerate

FDAOct 10, 2019Nationwide• Innoveix Pharmaceuticals Inc

Leucovorin Calcium Injection (Ingenus) – Crystallization Risk (2019)

Crystallization: Presence of particulate matter identified as API crystallization

Class IIModerate

FDAOct 9, 2019Nationwide• Ingenus Pharmaceuticals Llc

Amino Acid Injection (Nephron) – Sterility and Leak Risk (2019)

Lack of Assurance of Sterility; bags have potential to leak

Class IIModerate

FDAOct 9, 2019Nationwide• Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center

PF-Fentanyl Citrate (Nephron) – Glass Contamination (2019)

GMP Deviations: potential glass contamination

Class IIModerate

FDAOct 9, 2019Nationwide• Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center

del Nido Cardioplegia Solution (Nephron) – Sterility and Leak Risk (2019)

Lack of Assurance of Sterility; bags have potential to leak

Class IIModerate

FDAOct 9, 2019Nationwide• Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center

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