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Showing 25341–25360 of 29086 results

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Amlodipine Besylate and Benazepril HCl Capsules (Mylan) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Class IIModerate

FDASep 13, 2013Nationwide• Mylan Pharmaceuticals Inc.

Amlodipine Besylate and Benazepril HCl Capsules (Mylan) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Class IIModerate

FDASep 13, 2013Nationwide

• Mylan Pharmaceuticals Inc.

Amlodipine Besylate and Benazepril HCl Capsules (Mylan) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Class IIModerate

FDASep 13, 2013Nationwide• Mylan Pharmaceuticals Inc.

Amlodipine Besylate Tablets (Mylan) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Class IIModerate

FDASep 13, 2013Nationwide• Mylan Pharmaceuticals Inc.

Amlodipine Besylate and Benazepril HCl Capsules (Mylan) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Class IIModerate

FDASep 13, 2013Nationwide• Mylan Pharmaceuticals Inc.

Amlodipine Benazepril Capsules (Mylan) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Class IIModerate

FDASep 13, 2013Nationwide• Mylan Pharmaceuticals Inc.

Roasted Salted Mixed Nuts (Dutch Valley) – Undeclared Nuts (2013)

Undeclared Nuts

Roasted Salted Mixed Nuts with Peanuts were recalled for undeclared tree nuts (pecans) in the ingredient statement.

Class IIModerate

FDASep 12, 2013Nationwide• Dutch Valley Food Development Inc.

Honey Roasted Peanuts (Dutch Valley) – Undeclared Allergens (2013)

Undeclared Allergen

Honey Roasted Peanuts were recalled due to undeclared milk (lactose) and wheat (wheat starch) allergens in the ingredient statement.

Class IIModerate

FDASep 12, 2013Nationwide• Dutch Valley Food Development Inc.

Risperdal CONSTA (Janssen) – Non-Sterility Risk (2013)

Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample

Class IIModerate

FDASep 11, 2013Nationwide• Janssen Pharmaceuticals, Inc.

German Chocolate Cake Gelato (Talenti) – Undeclared Almonds (2013)

Undeclared Allergen

Product contains undeclared Allergen; Almonds.

Class IIModerate

FDASep 10, 2013AZ, CO, CT +14 more• Talenti Gelato

Carrot Cake Layers (Maplehurst) – Foreign Material (2013)

Product was found to contain foreign material, flexible plastic.

Class IIModerate

FDASep 10, 2013MI, OH• Maplehurst Bakeries, Inc.

Bevacizumab (Avella) – Sterility Concern (2013)

Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.

Class IIModerate

FDASep 9, 2013Nationwide• Avella of Deer Valley, Inc.

HCG Premium Energy Drops (Borinquen) – Unverified Claims (2013)

Distributed dietary supplements with the following claims in the firm's website: "prevents depression, hypertension, renal diseases, arthritis, cancer, diabetes, obesity, heart conditions, etc."

Class IIModerate

FDASep 9, 2013PR• Borinquen Natural

Multi For Him (Pharmavite) – Packaging Error (2013)

Pharmavite LLC is conducting a voluntary recall of all lots of its Nature Made Full Strength Mini Multivitamins (recently repackaged as "Multi" softgels, (Multi Complete, Multi for Her, Multi for Her 50+, Multi for Him, Multi Complete club size). because recent quality tests indicate that the Vitamins B1 and B12 are losing potency more rapidly than initially expected, and these products are not me

Class IIModerate

FDASep 9, 2013Nationwide• Pharmavite Corporation

Vancomycin PF (Avella) – Sterility Concern (2013)

Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.

Class IIModerate

FDASep 9, 2013Nationwide• Avella of Deer Valley, Inc.

Multi for Her (Pharmavite) – Packaging Error (2013)

Pharmavite LLC is conducting a voluntary recall of all lots of its Nature Made Full Strength Mini Multivitamins (recently repackaged as "Multi" softgels, (Multi Complete, Multi for Her, Multi for Her 50+, Multi for Him, Multi Complete club size). because recent quality tests indicate that the Vitamins B1 and B12 are losing potency more rapidly than initially expected, and these products are not me

Class IIModerate

FDASep 9, 2013Nationwide• Pharmavite Corporation

Multi for Her 50+ Vitamins (Pharmavite) – Voluntary Recall (2013)

Pharmavite LLC is conducting a voluntary recall of all lots of its Nature Made Full Strength Mini Multivitamins (recently repackaged as "Multi" softgels, (Multi Complete, Multi for Her, Multi for Her 50+, Multi for Him, Multi Complete club size). because recent quality tests indicate that the Vitamins B1 and B12 are losing potency more rapidly than initially expected, and these products are not me

Class IIModerate

FDASep 9, 2013Nationwide• Pharmavite Corporation

Multi Complete (Pharmavite) – Packaging Error (2013)

Pharmavite LLC is conducting a voluntary recall of all lots of its Nature Made Full Strength Mini Multivitamins (recently repackaged as "Multi" softgels, (Multi Complete, Multi for Her, Multi for Her 50+, Multi for Him, Multi Complete club size). because recent quality tests indicate that the Vitamins B1 and B12 are losing potency more rapidly than initially expected, and these products are not me

Class IIModerate

FDASep 9, 2013Nationwide• Pharmavite Corporation

HCG Premium Cleanse Drops (Borinquen) – Unverified Claims (2013)

Distributed dietary supplements with the following claims in the firm's website: "prevents depression, hypertension, renal diseases, arthritis, cancer, diabetes, obesity, heart conditions, etc."

Class IIModerate

FDASep 9, 2013PR• Borinquen Natural

HCG Premium Drops (Borinquen) – Unverified Claims (2013)

Distributed dietary supplements with the following claims: "drops the fat, expels toxins, break down fat, block carbohydrates, suppresses appetite, suppresses fat absorption, creates a balance in the thyroid". In addition, the firm's website claimed to repair body tissue, such as minor ulcers and to contain anti-cancer compounds.

Class IIModerate

FDASep 9, 2013PR• Borinquen Natural

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