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Showing 9921–9940 of 14370 results

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Hyaluronidase 150 U/mL Injectable (Montana Compounding) – sterility concern (2015)

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Class IIModerate

FDAMay 15, 2015MT, ND• Montana Compounding Pharmacy

Glutathione Nasal 100 mg/mL (Montana Compounding) – sterility concern (2015)

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Class IIModerate

FDAMay 15, 2015MT, ND• Montana Compounding Pharmacy

Avastin Injectable Solution (Montana Compounding) – sterility concern (2015)

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Class IIModerate

FDAMay 15, 2015MT, ND• Montana Compounding Pharmacy

Alprostadil 20 mcg/mL Injectable (Montana Compounding) – sterility concern (2015)

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Class IIModerate

FDAMay 15, 2015MT, ND• Montana Compounding Pharmacy

Trimix Injectable Solution (Montana Compounding) – sterility concern (2015)

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Class IIModerate

FDAMay 15, 2015MT, ND• Montana Compounding Pharmacy

Trimix Injectable Solution (Montana Compounding) – sterility concern (2015)

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Class IIModerate

FDAMay 15, 2015MT, ND• Montana Compounding Pharmacy

Trimix Injectable Solution (Montana Compounding) – sterility concern (2015)

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Class IIModerate

FDAMay 15, 2015MT, ND• Montana Compounding Pharmacy

Alprostadil 30 mcg/mL Injectable (Montana Compounding) – sterility concern (2015)

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Class IIModerate

FDAMay 15, 2015MT, ND• Montana Compounding Pharmacy

Glutathione Inhalation 100mg/mL (Montana Compounding) – sterility concern (2015)

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Class IIModerate

FDAMay 15, 2015MT, ND• Montana Compounding Pharmacy

Bimix Injectable Solution (Montana Compounding) – sterility concern (2015)

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Class IIModerate

FDAMay 15, 2015MT, ND• Montana Compounding Pharmacy

Trimix Injectable Solution (Montana Compounding) – sterility concern (2015)

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Class IIModerate

FDAMay 15, 2015MT, ND• Montana Compounding Pharmacy

Alprostadil 10 mcg/mL Injectable (Montana Compounding) – sterility concern (2015)

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Class IIModerate

FDAMay 15, 2015MT, ND• Montana Compounding Pharmacy

MD-Gastroview Contrast Solution (Mallinckrodt) – labeling issue (2015)

Labeling: incorrect or missing lot number and/or expiration date

Class IIModerate

FDAMay 15, 2015Nationwide• Mallinckrodt, Inc.

Fentanyl Citrate Injection (West-Ward) – Impurity Specification Failure (2015)

Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).

FDAMay 13, 2015Nationwide• West-Ward Pharmaceutical Corp.

Famotidine Tablets (Allegiant Health) – CGMP Complaint Investigation (2015)

CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints.

Class IIModerate

FDAMay 12, 2015Nationwide• Allegiant Health

Zebeta Tablets (Teva) – Dissolution Specification Failure (2015)

Failed Dissolution Specifications: OOS result during stability testing

Class IIModerate

FDAMay 11, 2015Nationwide• Teva Pharmaceuticals USA

Colostrum Capsules (Natural Creations) – Undeclared Allergen (2015)

Natural Creations announces allergy alert and voluntary recall of New Zealand Colostrum dietary supplement due to unidentified allergen inclusion (milk).

Class IIModerate

FDAMay 8, 2015Nationwide• Natural Creations Inc

QVAR Inhalation Aerosol (Teva) – Impurity Specification Failure (2015)

Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.

FDAMay 7, 2015Nationwide• Teva Pharmaceuticals USA

Amlodipine Atorvastatin 5/10mg (Dr. Reddy's) – Subpotent Medication (2015)

Subpotent drug

FDAMay 6, 2015Nationwide• Dr. Reddy's Laboratories, Inc.

Amlodipine Atorvastatin 5/40mg (Dr. Reddy's) – Subpotent Medication (2015)

Subpotent drug

FDAMay 6, 2015Nationwide• Dr. Reddy's Laboratories, Inc.

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