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Showing 10961–10980 of 14370 results

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Cyproheptadine HCl Syrup (Pharmaceutical Associates) – Impurity Issue (2014)

Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.

Class IIModerate

FDAOct 16, 2014Nationwide• Pharmaceutical Associates Inc

Candesartan Cilexetil Tablets (Apotex) – Impurity Specification Failure (2014)

Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.

FDAOct 16, 2014Nationwide• Apotex Inc.

Shark Cartilage Supplement (AMS Health) – Salmonella Risk (2014)

The product is being recalled due to the potential presence of Salmonella.

FDAOct 15, 2014Nationwide• AMS Health Sciences

Sodium Chloride Injection (Hospira) – sterility concern (2014)

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Class IIModerate

FDAOct 14, 2014Nationwide• Hospira Inc.

Dextrose Sodium Chloride Injection (Hospira) – Potential Container Leak (2014)

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Class IIModerate

FDAOct 14, 2014Nationwide• Hospira Inc.

Tri-mix #4 (Vann) – Sterility Concerns (2014)

Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.

Class IIModerate

FDAOct 14, 2014KY• Vann Healthcare Services Inc

Dextrose Injection (Hospira) – Potential Container Leak (2014)

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Class IIModerate

FDAOct 14, 2014Nationwide• Hospira Inc.

Hydroxyprogesterone Caproate (Vann) – Sterility Concerns (2014)

Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.

Class IIModerate

FDAOct 14, 2014KY• Vann Healthcare Services Inc

Sterile Water Injection (Hospira) – Potential Container Leak (2014)

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Class IIModerate

FDAOct 14, 2014Nationwide• Hospira Inc.

Epinephrine Syringes (Vann) – Sterility Concerns (2014)

Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.

Class IIModerate

FDAOct 14, 2014KY• Vann Healthcare Services Inc

Normosol-R Electrolytes (Hospira) – sterility risk (2014)

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Class IIModerate

FDAOct 14, 2014Nationwide• Hospira Inc.

Lactated Ringer's Dextrose (Hospira) – Potential Container Leak (2014)

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Class IIModerate

FDAOct 14, 2014Nationwide• Hospira Inc.

Lidocaine Syringes (Vann) – Sterility Concerns (2014)

Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.

Class IIModerate

FDAOct 14, 2014KY• Vann Healthcare Services Inc

Sodium Chloride Injection (Hospira) – Potential Container Leak (2014)

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Class IIModerate

FDAOct 14, 2014Nationwide• Hospira Inc.

Lactated Ringer's Injection (Hospira) – Potential Container Leak (2014)

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Class IIModerate

FDAOct 14, 2014Nationwide• Hospira Inc.

Dextrose Sodium Chloride Injection (Hospira) – sterility risk (2014)

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Class IIModerate

FDAOct 14, 2014Nationwide• Hospira Inc.

Potassium Chloride Injection (Hospira) – Potential Container Leak (2014)

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Class IIModerate

FDAOct 14, 2014Nationwide• Hospira Inc.

Normosol-R Electrolytes (Hospira) – Potential Container Leak (2014)

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Class IIModerate

FDAOct 14, 2014Nationwide• Hospira Inc.

Hello Blossom Capsules (Herb Garden) – Salmonella Potential (2014)

Notified by immediate supplier that Nettle Leaf Powder may contain Salmonella after reports of a positive finding by a customer.

FDAOct 14, 2014NV• Herb Garden Productions

Premium Protein III (Triceutical Inc.) – Manufacturing practices (2014)

Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices.

FDAOct 10, 2014FL, NY, PA• Triceutical Inc./Zhang

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