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Showing 2021–2040 of 2326 results

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Valsartan Tablets (Mylan) – impurity risk (2018)

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Class IIModerate

FDANov 20, 2018Nationwide• Mylan Pharmaceuticals Inc.

Amlodipine, Valsartan Tablets (Mylan) – impurity risk (2018)

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Class IIModerate

FDANov 20, 2018Nationwide• Mylan Pharmaceuticals Inc.

Turkey Hill Vanilla Ice Cream (Hunter Farms) – Mislabeled Ingredients (2018)

Package did not contain Vanilla Bean Ice Cream but Cotton Candy Ice Cream, which contains soy lecithin that is not listed on the Vanilla Bean label.

Class IIModerate

FDANov 15, 2018IN, PA• Harris Teeter Supermarkets, LLC dba Hunter Farms

Losartan Potassium Tablets (Sandoz) – NDEA Impurity (2018)

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Class IIModerate

FDANov 1, 2018OH, PR• Sandoz, Inc

Fit & Active Veggie Stuffed Sandwiches (J&J Snack Foods) – potential contamination (2018)

The firm was notified by their supplier that the vegetables used in the product were possibly contaminated with Listeria monocytogenes and Salmonella.

Class IIModerate

FDAOct 29, 2018CT, FL, GA +4 more• J&J Snack Foods Handheld Corp

House Blend Barbecue Sauce (Diamond Crystal) – Incorrect Label (2018)

During a label check the firm noticed that the product was shipped with the incorrect label. The label is missing the following ingredients: Soybean Oil, Onion Powder & EDTA.

Class IIModerate

FDAOct 15, 2018CA, GA, IL +8 more• Diamond Crystal Brands, Inc.

Pre Proof Danish (Bake One) – Foreign Plastic Contamination (2018)

The firm found what appeared to be plastic in the product.

Class IIModerate

FDAOct 5, 2018GA, IN, LA +7 more• Bake One, Inc.

Sprite (Coca-Cola) – plastic contamination (2018)

Product contains plastic material.

Class IIModerate

FDASep 12, 2018IL, IN, KY +3 more• COCA COLA BOTTLING COMPAN

Diet Coke (Coca-Cola) – plastic material (2018)

Product contains plastic material.

Class IIModerate

FDASep 12, 2018IL, IN, KY +3 more• COCA COLA BOTTLING COMPAN

Caffeine Free Diet Coke (Coca-Cola) – plastic contamination (2018)

Product contains plastic material.

Class IIModerate

FDASep 12, 2018IL, IN, KY +3 more• COCA COLA BOTTLING COMPAN

Amlodipine/Valsartan Tablets 10/320mg (Torrent Pharma) – carcinogen impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class IIModerate

FDAAug 17, 2018Nationwide• Torrent Pharma Inc.

Amlodipine/Valsartan/HCTZ Tablets 5/160/25mg (Torrent Pharma) – carcinogen impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class IIModerate

FDAAug 17, 2018Nationwide• Torrent Pharma Inc.

Valsartan Tablets 160mg (Torrent Pharma) – carcinogen impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class IIModerate

FDAAug 17, 2018Nationwide• Torrent Pharma Inc.

Amlodipine/Valsartan/HCTZ Tablets 10/160/25mg (Torrent Pharma) – carcinogen impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class IIModerate

FDAAug 17, 2018Nationwide• Torrent Pharma Inc.

Amlodipine/Valsartan Tablets 5/160mg (Torrent Pharma) – carcinogen impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class IIModerate

FDAAug 17, 2018Nationwide• Torrent Pharma Inc.

Valsartan Tablets 80mg (Torrent Pharma) – carcinogen impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class IIModerate

FDAAug 17, 2018Nationwide• Torrent Pharma Inc.

Amlodipine/Valsartan Tablets 5/320mg (Torrent Pharma) – carcinogen impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class IIModerate

FDAAug 17, 2018Nationwide• Torrent Pharma Inc.

Amlodipine/Valsartan/HCTZ Tablets 10/160/12.5mg (Torrent Pharma) – carcinogen impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class IIModerate

FDAAug 17, 2018Nationwide• Torrent Pharma Inc.

Amlodipine/Valsartan Tablets 10/160mg (Torrent Pharma) – carcinogen impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class IIModerate

FDAAug 17, 2018Nationwide• Torrent Pharma Inc.

Amlodipine/Valsartan/HCTZ Tablets 10/320/25mg (Torrent Pharma) – carcinogen impurity (2018)

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Class IIModerate

FDAAug 17, 2018Nationwide• Torrent Pharma Inc.

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