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Showing 11481–11500 of 14370 results

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Papaverine HCl Injection (John W Hollis) – sterility risk (2014)

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

Class IIModerate

FDAMay 12, 2014Nationwide• John W Hollis Inc

Papaverine HCl Injection Combo (John W Hollis) – Sterility Risk (2014)

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

Class IIModerate

FDAMay 12, 2014Nationwide• John W Hollis Inc

Methylcobalamin Injection (John W Hollis) – Sterility Risk (2014)

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

Class IIModerate

FDAMay 12, 2014Nationwide• John W Hollis Inc

Polidocanol 5% Injection (John W Hollis) – sterility risk (2014)

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

Class IIModerate

FDAMay 12, 2014Nationwide• John W Hollis Inc

Levocarnitine Solution (John W Hollis) – Sterility Risk (2014)

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

Class IIModerate

FDAMay 12, 2014Nationwide• John W Hollis Inc

Coumadin Injection (Bristol-Meyers Squibb) – particulate matter (2014)

Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic cellulose fiber particles found in retain vials

FDAMay 12, 2014Nationwide• Bristol-Meyers Squibb

Polidocanol 1% Injection (John W Hollis) – sterility risk (2014)

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

Class IIModerate

FDAMay 12, 2014Nationwide• John W Hollis Inc

Testosterone Cypionate (John W Hollis) – sterility risk (2014)

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

Class IIModerate

FDAMay 12, 2014Nationwide• John W Hollis Inc

Cyanocobalamin Injection (John W Hollis) – sterility risk (2014)

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

Class IIModerate

FDAMay 12, 2014Nationwide• John W Hollis Inc

Promethazine Tablets (Zydus) – Foreign Tablet Mix (2014)

Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.

Class IIModerate

FDAMay 8, 2014Nationwide• Zydus Pharmaceuticals USA Inc

Mojo Risen Capsules (Eugene Oregon) – Undeclared Sildenafil (2014)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.

FDAMay 5, 2014FL, IL, IN +8 more• Eugene Oregon, Inc.

Black Ant Capsules (Eugene Oregon) – Undeclared Sildenafil (2014)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.

FDAMay 5, 2014FL, IL, IN +8 more• Eugene Oregon, Inc.

African Black Ant Capsules (Eugene Oregon) – Undeclared Sildenafil (2014)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.

FDAMay 5, 2014FL, IL, IN +8 more• Eugene Oregon, Inc.

Performance Plus (Good Herbs) – Manufacturing Violations (2014)

Products not manufactured under GMP's

Class IIModerate

FDAMay 5, 2014AZ, CA, CT +15 more• Good Herbs, Inc.

Healthy Digestion (Good Herbs) – Manufacturing Violation (2014)

Products not manufactured under GMP's

Class IIModerate

FDAMay 5, 2014AZ, CA, CT +15 more• Good Herbs, Inc.

Pro Vitality Plus (Good Herbs) – Manufacturing Violation (2014)

Products not manufactured under GMP's

Class IIModerate

FDAMay 5, 2014AZ, CA, CT +15 more• Good Herbs, Inc.

PRO VITALITY Capsules (Good Herbs, Inc.) – Manufacturing Violations (2014)

Products not manufactured under GMP's

Class IIModerate

FDAMay 5, 2014AZ, CA, CT +15 more• Good Herbs, Inc.

Rose Hips (Good Herbs) – Manufacturing Concerns (2014)

Products not manufactured under GMP's

Class IIModerate

FDAMay 5, 2014AZ, CA, CT +15 more• Good Herbs, Inc.

Spirulina (Good Herbs) – Manufacturing Concerns (2014)

Products not manufactured under GMP's

Class IIModerate

FDAMay 5, 2014AZ, CA, CT +15 more• Good Herbs, Inc.

LVGL Capsules (Good Herbs) – Manufacturing Violation (2014)

Products not manufactured under GMP's

Class IIModerate

FDAMay 5, 2014AZ, CA, CT +15 more• Good Herbs, Inc.

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