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Showing 11341–11360 of 11714 results

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Ladyfingers Country Ham Rolls (Ladyfingers Catering) – Listeria Risk (2018)

The firm was notified by their vendor that the product may be contaminated with Listeria monocytogenes.

FDAOct 5, 2018CA, DE, GA +5 more• Ladyfingers Catering, LLC

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.

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

Sprite (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 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.

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.

Valsartan Tablets 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 5/160/12.5mg (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/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/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.

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 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.

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.

Montelukast Sodium Tablets (Hetero Labs) – label mix-up (2018)

Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.

FDAAug 15, 2018Nationwide• Hetero Labs Limited Unit V

Peanut Paste/Butter (Peanut Processors) – Salmonella Contamination (2018)

The firm was notified by a customer that the product test positive for Salmonella

FDAJul 20, 2018AR, TN• Peanut Processors, Inc.

Valsartan Tablets (A-S Medication) – Carcinogen Impurity (2018)

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

Class IIModerate

FDAJul 17, 2018Nationwide• A-S Medication Solutions LLC.

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