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Showing 441–460 of 470 results

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CJC-1295 (Advanced Nutriceuticals) – Sterility Concerns (2020)

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Class IIModerate

FDANov 30, 2020CA, CO, FL +4 more• Advanced Nutriceuticals, LLC

AOD-9604 (Advanced Nutriceuticals) – Sterility Concerns (2020)

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Class IIModerate

FDANov 30, 2020CA, CO, FL +4 more• Advanced Nutriceuticals, LLC

GHK-CU (Advanced Nutriceuticals) – Sterility Concerns (2020)

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Class IIModerate

FDANov 30, 2020CA, CO, FL +4 more• Advanced Nutriceuticals, LLC

Ranitidine Syrup (Amneal) – NDMA Impurity (2019)

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Class IIModerate

FDANov 22, 2019Nationwide• Amneal Pharmaceuticals, Inc.

Zantac Regular Strength (Sanofi) – NDMA impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 22, 2019Nationwide• Sanofi-Aventis U.S. LLC

Zantac Maximum Strength (Sanofi) – NDMA impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 22, 2019Nationwide• Sanofi-Aventis U.S. LLC

Zantac Regular Strength (Sanofi) – NDMA impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 22, 2019Nationwide• Sanofi-Aventis U.S. LLC

Zantac Regular Strength (Sanofi) – NDMA impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 22, 2019Nationwide• Sanofi-Aventis U.S. LLC

Zantac Regular Strength (Sanofi) – NDMA impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 22, 2019Nationwide• Sanofi-Aventis U.S. LLC

Zantac Regular Strength (Sanofi) – NDMA impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 22, 2019Nationwide• Sanofi-Aventis U.S. LLC

Zantac Tablets (Sanofi) – NDMA impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 22, 2019Nationwide• Sanofi-Aventis U.S. LLC

Zantac Maximum Strength (Sanofi) – NDMA impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 22, 2019Nationwide• Sanofi-Aventis U.S. LLC

Zantac Cool Mint Maximum Strength (Sanofi) – NDMA impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 22, 2019Nationwide• Sanofi-Aventis U.S. LLC

Zantac (Sanofi) – NDMA Impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 22, 2019Nationwide• Sanofi-Aventis U.S. LLC

Zantac Regular Strength (Sanofi) – NDMA Impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 22, 2019Nationwide• Sanofi-Aventis U.S. LLC

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

Double Hyaluronic Cream (Signature Club A) - Microbial Contamination (2017)

Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial contamination.

Class IIModerate

FDAMar 1, 2017Nationwide• Signature Club A Ltd

NSM Extra Fine Sugar (National Sugar) – foreign material (2017)

Foreign material (rubber) detected in product.

Class IIModerate

FDAFeb 9, 2017GA• National Sugar Marketing LLC

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