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Showing 14701–14720 of 15081 results

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Endurance Pre Race Pina Colada Supplement (Maine Natural Health) – Undeclared Milk (2012)

Protein supplement fails to declare allergens: milk

FDASep 21, 2012Nationwide• Maine Natural Health, Inc.

Children's Cetirizine HCl Tablets (Sandoz) – Impurity Specification (2012)

Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)

FDASep 20, 2012Nationwide• Sandoz Incorporated

SLIM XTREME Herbal Capsules (Globe Wellness) – Unapproved Ingredient (2012)

Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.

Class IHigh

FDASep 20, 2012Nationwide• Globe All Wellness, LLC

Fruit Tray (Caito Foods) – Mango contamination warning (2012)

In cooperation with the FDA warning to not consume mangoes from Agricola Daniella, Mexico. FreshLine of Indianapolis, Indiana, has initiated a voluntary recall of a limited quantity of expired products that contain fresh-cut mangoes due to the potential risk that the mangoes may contain Salmonella.

FDASep 15, 2012Nationwide• Caito Foods Service, Inc.

Signature Cafe Fruit Basket Medley (GHSW) – Salmonella risk (2012)

The product has the potential to be contaminated with Salmonella. Contains mangoes sourced from Agricola Daniella.

FDASep 15, 2012FL, LA, TX• GHSW, LLC

Pramipexole Tablets 0.125mg (Sandoz) – Impurity Concern (2012)

Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.

FDASep 12, 2012Nationwide• Sandoz Incorporated

Pramipexole Tablets 0.25mg (Sandoz) – Impurity Concern (2012)

Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.

FDASep 12, 2012Nationwide• Sandoz Incorporated

Cymevene Infusion (Roche) – Sterility Issue (2012)

Lack of Assurance of Sterility; container closure issues with the bulk batch.

Class IIModerate

FDASep 5, 2012IN• F. Hoffmann-LaRoche Ltd.

Equate Fiber Therapy (Raritan Pharmaceuticals) – C. difficile contamination (2012)

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Class IIModerate

FDASep 4, 2012Nationwide• Raritan Pharmaceuticals, Inc.

Up&Up Psyllium Fiber Supplement (Raritan Pharmaceuticals) – C. difficile contamination (2012)

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Class IIModerate

FDASep 4, 2012Nationwide• Raritan Pharmaceuticals, Inc.

Wal-Mucil Fiber Supplement (Raritan) – Microbial Risk (2012)

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Class IIModerate

FDASep 4, 2012Nationwide• Raritan Pharmaceuticals, Inc.

Wal-Mucil Plus Calcium Fiber Capsules (Raritan Pharmaceuticals) – C. difficile contamination (2012)

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Class IIModerate

FDASep 4, 2012Nationwide• Raritan Pharmaceuticals, Inc.

Simply Right Healthcare Fiber Capsules (Raritan Pharmaceuticals) – C. difficile contamination (2012)

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Class IIModerate

FDASep 4, 2012Nationwide• Raritan Pharmaceuticals, Inc.

Premier Value Fiber Calcium Capsules (Raritan) – Microbial Risk (2012)

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Class IIModerate

FDASep 4, 2012Nationwide• Raritan Pharmaceuticals, Inc.

Leader Fiber Capsules (Raritan) – Microbial Risk (2012)

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Class IIModerate

FDASep 4, 2012Nationwide• Raritan Pharmaceuticals, Inc.

Best Choice Health Care Psyllium Fiber (Raritan Pharmaceuticals) – C. difficile contamination (2012)

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Class IIModerate

FDASep 4, 2012Nationwide• Raritan Pharmaceuticals, Inc.

DRxChoice Fiber Capsules (Raritan Pharmaceuticals) – C. difficile contamination (2012)

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Class IIModerate

FDASep 4, 2012Nationwide• Raritan Pharmaceuticals, Inc.

Premier Value Fiber Capsules (Raritan) – Microbial Risk (2012)

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Class IIModerate

FDASep 4, 2012Nationwide• Raritan Pharmaceuticals, Inc.

Berkley & Jensen Fiber Capsules (Raritan) – Microbial Risk (2012)

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Class IIModerate

FDASep 4, 2012Nationwide• Raritan Pharmaceuticals, Inc.

CVS Fiber Capsules (Raritan) – Microbial Risk (2012)

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Class IIModerate

FDASep 4, 2012Nationwide• Raritan Pharmaceuticals, Inc.

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