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Showing 9621–9640 of 14370 results

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Prostaglandin E1 Injection (Apothecary) – sterility monitoring (2015)

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Class IIModerate

FDAJun 26, 2015OK• The Apothecary Shoppe LLC

SIU-Tri-Mix 24/1/20 Injection (Apothecary Shoppe) – sterility concern (2015)

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Class IIModerate

FDAJun 26, 2015OK• The Apothecary Shoppe LLC

Caribbean Fruit & Nut Mix (Natural Grocers) – Allergen Warning (2015)

Salmonella

Vitamin Cottage Natural Food Markets, Inc is recalling one lot of Natural Grocers brand Caribbean Nut & Fruit Mix as the product contains macadamia nuts that have the potential to be contaminated with Salmonella.

Class IHigh

FDAJun 26, 2015Nationwide• Vitamin Cottage Natural Food Markets, Inc.

Phent/PGE1 Injection (Apothecary) – sterility monitoring (2015)

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Class IIModerate

FDAJun 26, 2015OK• The Apothecary Shoppe LLC

Dextroamphetamine Combination (Teva) – impurity specification (2015)

Failed Impurities/Degradation Specifications: out of specification for unknown impurity

Class IIModerate

FDAJun 24, 2015Nationwide• Teva Pharmaceuticals USA

Desmopressin Acetate Tablets (Actavis) – Incorrect Tablet Imprint (2015)

Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.

FDAJun 23, 2015Nationwide• Actavis Laboratories, FL, Inc.

Cortisol-MC Capsules (Abrams Royal) – dosage uniformity issue (2015)

Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications.

FDAJun 23, 2015Nationwide• Abrams Royal Pharmacy II, LLC

c-Budesonide Capsules (Solutions Rx) – Penicillin Cross Contamination (2015)

Penicillin Cross Contamination - Possible presence of penicillin in bulk budesonide powder used to compound prescription nasal rinse/nebulizer capsules.

Class IIModerate

FDAJun 22, 2015AL, GA, LA +1 more• Solutions Rx Pharmacy

Disulfiram Tablets (Qualitest) – Failed Dissolution Test (2015)

Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for dissolution.

FDAJun 18, 2015Nationwide• Qualitest Pharmaceuticals

Papervine/Phentolamine/PGE-1 Injectable (Liberty Drug) – sterility concern (2015)

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Class IIModerate

FDAJun 15, 2015IN, NJ, NY• Liberty Drug & Surgical

Glycerin Injection (Liberty Drug) – Sterility Concern (2015)

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Class IIModerate

FDAJun 15, 2015IN, NJ, NY• Liberty Drug & Surgical

Morphine IV Bag (Liberty Drug) – Sterility Concern (2015)

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Class IIModerate

FDAJun 15, 2015IN, NJ, NY• Liberty Drug & Surgical

Lidocaine/Sodium Chloride Injectable (Liberty Drug) – Sterility Concern (2015)

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Class IIModerate

FDAJun 15, 2015IN, NJ, NY• Liberty Drug & Surgical

Methadone Injection (Liberty Drug) – Sterility Concern (2015)

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Class IIModerate

FDAJun 15, 2015IN, NJ, NY• Liberty Drug & Surgical

17-Hydroxyprogesterone Injectable (Liberty Drug) – sterility concern (2015)

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Class IIModerate

FDAJun 15, 2015IN, NJ, NY• Liberty Drug & Surgical

Papaverine/Phentolamine/Atropine/PGE-1 Injectable (Liberty Drug) – Sterility Concern (2015)

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Class IIModerate

FDAJun 15, 2015IN, NJ, NY• Liberty Drug & Surgical

Dexamethasone Injectable (Liberty Drug) – sterility concern (2015)

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Class IIModerate

FDAJun 15, 2015IN, NJ, NY• Liberty Drug & Surgical

Papaverine/Phentolamine/PGE-1 Injectable (Liberty Drug) – Sterility Concern (2015)

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Class IIModerate

FDAJun 15, 2015IN, NJ, NY• Liberty Drug & Surgical

Tobramycin Ophthalmic Solution (Liberty Drug) – Sterility Concern (2015)

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Class IIModerate

FDAJun 15, 2015IN, NJ, NY• Liberty Drug & Surgical

Papaverine/Phentolamine/Atropine/PGE-1 Injectable (Liberty Drug) – Sterility Concern (2015)

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Class IIModerate

FDAJun 15, 2015IN, NJ, NY• Liberty Drug & Surgical

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