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Showing 24341–24360 of 29086 results

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Indomethacin Capsules (Teva) – Manufacturing Deviation (2014)

CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.

Class IIModerate

FDAMar 24, 2014Nationwide• Teva Pharmaceuticals USA

Fire Roasted Salsa (Parkers Farm) – Listeria Risk (2014)

Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.

Class IIModerate

FDAMar 21, 2014Nationwide

• Parkers Farm Inc

Black Bean Roasted Chili Salsa (Parkers Farm) – Listeria contamination (2014)

Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.

Class IIModerate

FDAMar 21, 2014Nationwide• Parkers Farm Inc

Mild Salsa (Parkers Farm) – Listeria risk (2014)

Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.

Class IIModerate

FDAMar 21, 2014Nationwide• Parkers Farm Inc

El Original Quesipan (Hot Pandeyuca) – Undeclared ingredients (2014)

During an FDA inspection, it was discovered that the label of several products failed to declare the components ingredients of a butter flavor that included allergens FD&C Yellow #5, FD&C Yellow #6 and FD&C Red #40.

Class IIModerate

FDAMar 21, 2014FL, NC• Hot Pandeyuca & Company Inc

El Original Soft Bread (Hot Pandeyuca) – Undeclared ingredients (2014)

During an FDA inspection, it was discovered that the label of several products failed to declare the components ingredients of a butter flavor that included allergens FD&C Yellow #5, FD&C Yellow #6 and FD&C Red #40.

Class IIModerate

FDAMar 21, 2014FL, NC• Hot Pandeyuca & Company Inc

Garlic Salsa (Parkers Farm) – Listeria risk (2014)

Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.

Class IIModerate

FDAMar 21, 2014Nationwide• Parkers Farm Inc

Ace Cherry Berry Flossugar (Gold Medal) – High flavor concentration (2014)

Flavor concentration is too high

Class IIModerate

FDAMar 21, 2014Nationwide• Gold Medal Products

Hot Salsa (Parkers Farm) – Listeria risk (2014)

Various Peanut butters, cheese spreads, cold pack cheese, salsa, cheese balls/logs have the potential to be contaminated with Listeria monocytogenes.

Class IIModerate

FDAMar 21, 2014Nationwide• Parkers Farm Inc

Artificial Cherry Concentrate (Gold Medal) – High flavor concentration (2014)

Flavor concentration is too high

Class IIModerate

FDAMar 21, 2014Nationwide• Gold Medal Products

ParaGard T 380A Copper IUD (Teva) – Non-Sterile Device (2014)

Non-sterility: due to a failed sterility test

Class IIModerate

FDAMar 21, 2014KY, NY• Teva Pharmaceuticals USA

Cherry Glaze Pop (Gold Medal) – Flavor concentration issue (2014)

Flavor concentration is too high

Class IIModerate

FDAMar 21, 2014Nationwide• Gold Medal Products

Artificial Cherry Kola Flavoring (Gold Medal) – High concentration (2014)

Flavor concentration is too high

Class IIModerate

FDAMar 21, 2014Nationwide• Gold Medal Products

Eggo Buttermilk Waffles (Kellogg's) – Plastic contamination (2014)

There may be small pieces of plastic found in a limited number of Eggo Buttermilk waffles distributed in Canada.

Class IIModerate

FDAMar 21, 2014IN• Kellogg Company

Cheese Bread (Hot Pandeyuca) – Ingredient Labeling Issue (2014)

During an FDA inspection, it was discovered that the label of several products failed to declare the components ingredients of a butter flavor that included allergens FD&C Yellow #5, FD&C Yellow #6 and FD&C Red #40.

Class IIModerate

FDAMar 21, 2014FL, NC• Hot Pandeyuca & Company Inc

Honey Roasted Peanuts (Fisher) – Packaging contamination (2014)

Cases containing 12 x 14 oz. plastic jars of Fisher "Honey Roasted Peanuts Dry Roasted" with a "Best By" date of "5/20/15 N" may contain plastic jars that are mislabeled as Fisher "Peanuts Dry Roasted Golden Roast". Dry roasted honey roasted peanuts contain wheat, which is an allergen, and this allergen is not declared on the dry roasted peanut label.

Class IIModerate

FDAMar 20, 2014IL, IA, WI• John B. Sanfilippo & Son Inc.

Venlafaxine ER Tablets 37.5mg (Caraco) – Dissolution Failure (2014)

Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.

Class IIModerate

FDAMar 20, 2014Nationwide• Caraco Pharmaceutical Laboratories, Ltd.

Venlafaxine ER Tablets 150mg (Caraco) – Dissolution Failure (2014)

Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.

Class IIModerate

FDAMar 20, 2014Nationwide• Caraco Pharmaceutical Laboratories, Ltd.

Eggnog Milk Bars (Helados La Tapatia) – Listeria contamination (2014)

FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.

Class IIModerate

FDAMar 19, 2014AZ, CA, NV +1 more• Helados La Tapatia, Inc

Jamaica Fruit Bar (Helados La Tapatia) – Listeria contamination (2014)

FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.

Class IIModerate

FDAMar 19, 2014AZ, CA, NV +1 more• Helados La Tapatia, Inc

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