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Showing 521–540 of 548 results

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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 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 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 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 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

Diet Coke (Coca-Cola) – plastic material (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

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

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

GAC Supplement (Tri-Coast) – sterility concern (2016)

Lack of Assurance of Sterility

Class IIModerate

FDANov 17, 2016Nationwide• Tri-Coast Pharmacy

Blue Crab Spread (Inland Seafood) – wood contamination (2016)

Possible contamination with foreign matter; wood pieces.

Class IIModerate

FDAAug 19, 2016CT, FL, GA +8 more• Inland Seafood, Inc.

Maine Lobster Spread (Inland Seafood) – wood contamination (2016)

Possible contamination with foreign matter; wood pieces.

Class IIModerate

FDAAug 19, 2016CT, FL, GA +8 more• Inland Seafood, Inc.

Green Raisin (Commerce International) – undeclared sulfites (2016)

Undeclared Allergen

Initiated by the Florida Department of Agriculture and Consumer Services due to undeclared sulfites on the finished product label.

FDAAug 5, 2016FL, GA, NC +1 more• Commerce International Inc.

Green Raisin (Commerce International) – undeclared sulfites (2016)

Undeclared Allergen

Initiated by the Florida Department of Agriculture and Consumer Services due to undeclared sulfites on the finished product label.

FDAAug 5, 2016FL• Commerce International Inc.

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