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Showing 3181–3200 of 3363 results

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Divalproex Sodium Tablets (Upsher Smith) – Labeling Error (2012)

Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.

FDADec 10, 2012Nationwide• Upsher Smith Laboratories, Inc.

Bronkaid Dual Action (Bayer) - missing label warning (2012)

Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label.

FDADec 7, 2012Nationwide• Bayer Healthcare, LLC

Clean & Clear Wash (Johnson & Johnson) - salicylic acid (2012)

Superpotent (Single Ingredient Drug): salicylic acid

FDADec 4, 2012Nationwide• Johnson & Johnson

Mandarin Oranges (Acme Food Sales) – Chemical Taste Issue (2012)

The firm received two consumer complaints regarding chemical smell/taste and tasting like the can. As a result the firm began extensive testing of its inventory. Preliminary testing identified a contaminant was present. Further testing is pending to specifically identify the contaminant.

FDANov 30, 2012UT• Acme Food Sales, Inc

Carisoprodol Tablets (West-ward) - DEA schedule change (2012)

Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV (C-IV)controlled substance. This product is being recalled because this controlled product was not relabeled with the required "C-IV" imprint on the label for products distributed after the 06/11/12 deadline.

FDANov 30, 2012Nationwide• West-ward Pharmaceutical Corp.

Apricot Pecan Flats (Unified Grocers) – Undeclared Sulfites (2012)

Undeclared Allergen

Unified Grocers is recalling Pure Apricot Pecan Flats because it may contain undeclared sulfites.

FDANov 30, 2012Nationwide• Unified Grocers Inc.

TORISEL Injection (Pfizer) – sterility risk (2012)

Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.

FDANov 26, 2012Nationwide• Pfizer Inc.

Derma-Smoothe/FS Scalp Oil (Hill) – subpotent medication (2012)

Subpotent; 22 month stability timepoint

FDANov 21, 2012Nationwide• Hill Dermaceuticals, Inc.

Derma-Smoothe/FS Body Oil (Hill) – subpotent medication (2012)

Subpotent; 12 month stability timepoint

FDANov 21, 2012Nationwide• Hill Dermaceuticals, Inc.

Cebada Barley Flour (Family Food) – undeclared colors (2012)

Undeclared Allergen

Mama Tere Cebada Flour contains undeclared colors Red #3 and Red #40.

FDANov 20, 2012NJ, NY, OH• Family Food Distributor, Inc.

EstroGel (Ascend) – defective pump mechanism (2012)

Defective Container: Pump head detaching from the canister unit upon removal of the overcap.

FDANov 19, 2012Nationwide• Ascend Therapeutics Inc

Raspberry Flavor (Bakery Cash & Carry) – Undeclared ingredients (2012)

The firm re-packs the bulk product for retail sale without labeling, just the name of the product handwritten. Therefore, the label does not declare allergens: FD&C Red #40 and Blue #1

FDANov 15, 2012PR• Bakery Cash & Carry Inc.

Panettone Chocolate (Whole Foods) – packaging error (2012)

The reason for the recall was that a small portion of the Whole Foods Market Cranberry Panettone was mispackaged in Whole Foods Market Panettone Chocolate boxes. Allergens are declared on both labels, but the only difference is that soy is in the 'may contains' statement on Whole Foods Market Cranberry Panettone box and on the Whole Foods Market Chocolate Panettone box, soy is declared in the 'con

FDANov 8, 2012Nationwide• Whole Foods Market

Mexican Style Tortilla Chips (El Matador) – ingredient quality (2012)

Beginning 11/01/2012 Garden Fresh Gourmet recalled El Matador & Garden Fresh Gourmet Salted Tortilla Chips because quality standards of ingredients used in the products were not met.

FDANov 1, 2012IN, MI, NJ• Garden Fresh Salsa, Inc.

Nacho Cheese Tortilla Chips (Garden Fresh) – ingredient quality (2012)

Beginning 11/01/2012 Garden Fresh Gourmet recalled Garden Fresh Nacho Cheese Tortilla chips (exp 11/26/2012) because quality standards of ingredients used in the products were not met.

FDANov 1, 2012IN, MI, NJ• Garden Fresh Salsa, Inc.

Kettle Style Original Tortilla Chips (Garden Fresh) – ingredient quality (2012)

Beginning 11/01/2012 Garden Fresh Gourmet recalled El Matador & Garden Fresh Gourmet Salted Tortilla Chips because quality standards of ingredients used in the products were not met.

FDANov 1, 2012IN, MI, NJ• Garden Fresh Salsa, Inc.

Saki Ika Cuttlefish Hot (JFC International) – Mold Contamination (2012)

Laceration Risk

JFC International is recalling WelPac Saki Ika Cuttlefish because of mold.

FDAOct 31, 2012Nationwide• J F C International Inc

Saki Ika Cuttlefish (JFC International) – Mold Contamination (2012)

Laceration Risk

JFC International is recalling WelPac Saki Ika Cuttlefish because of mold.

FDAOct 31, 2012Nationwide• J F C International Inc

Almond Breeze Milk (HP Hood) – Undeclared Chocolate (2012)

Undeclared Allergen

Product labeled as Unsweetened Vanilla Blue Diamond Almond Breeze Almond milk may contain chocolate flavored Almondmilk ( undeclared ingredients: cocoa and evaporated cane juice).

FDAOct 30, 2012CT, FL, GA +5 more• HP Hood LLC

Advair HFA Inhaler (GlaxoSmithKline) – Particle Distribution Issue (2012)

Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.

FDAOct 24, 2012Nationwide• GlaxoSmithKline, LLC.

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