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Showing 2061–2080 of 2326 results

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Valsartan (Prinston) – Carcinogen Impurity (2018)

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

Class IIModerate

FDAJul 13, 2018Nationwide• Prinston Pharmaceutical Inc

Valsartan and Hydrochlorothiazide (Prinston) – Carcinogen Impurity (2018)

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

Class IIModerate

FDAJul 13, 2018Nationwide• Prinston Pharmaceutical Inc

Valsartan (Prinston) – Carcinogen Impurity (2018)

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

Class IIModerate

FDAJul 13, 2018Nationwide• Prinston Pharmaceutical Inc

Valsartan (Prinston) – Carcinogen Impurity (2018)

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

Class IIModerate

FDAJul 13, 2018Nationwide• Prinston Pharmaceutical Inc

Admelog Solostar (Sanofi-Aventis) – Temperature Abuse (2018)

Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.

Class IIModerate

FDAJul 5, 2018Nationwide• Sanofi-Aventis U.S. LLC

Shortbread Lemon Infused (Heritage) – undeclared wheat (2018)

During a South Carolina State Department inspection the firm was notified that the label did not list wheat as an ingredient.

Class IIModerate

FDAMay 1, 2018CT, UT• Heritage Short Bread, Inc.

Emerald Glazed Walnuts (Snyder's-Lance) – undeclared nuts (2018)

Undeclared Nuts

Snyder's Lance is voluntarily recalling 6.5 oz. Emerald brand walnuts due to the presence of undeclared peanuts, almonds, cashews, and pecans.

Class IIModerate

FDAFeb 21, 2018Nationwide• Snyder's-Lance Inc.

Ventolin HFA Inhaler (GlaxoSmithKline) – Delivery System Defect (2017)

Defective Delivery System: Elevated number of units with out of specification results for leak rate

Class IIModerate

FDAMay 16, 2017Nationwide• GlaxoSmithKline, LLC

Mushroom Ricotta Ravioli (Kite Hill) – missing ingredient (2017)

Ingredient statement for Lyrical Foods Mushroom and Ricotta Flavor Ravioli does not include the ingredient of garlic.

Class IIModerate

FDAMay 11, 2017CA, FL, IN +4 more• Lyrical Foods Inc

Ventolin HFA (GlaxoSmithKline) – Defective Delivery System (2017)

Defective Delivery System: Elevated number of units with out of specification results for leak rate.

Class IIModerate

FDAMar 22, 2017Nationwide• GlaxoSmithKline, LLC

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

Frozen Ajiaco (Barberi International) – Listeria Risk (2017)

Contamination with Listeria monocytogenes

Class IIModerate

FDAJan 25, 2017FL• Barberi International Inc.

Egg Bagel (O'Pelle Bakery) – Undeclared Yellow 5 (2016)

The Egg Bagel flavor lacks declaration of Yellow 5 on its label.

Class IIModerate

FDADec 9, 2016FL• O'Pelle Enterprises, Inc.

Rainbow Bagel (O'Pelle) – Undeclared Colors (2016)

The Rainbow Bagel flavor label lacks declaration of Yellow 5, Yellow 6, Blue 1, Red 40 and Red 3 on its label.

Class IIModerate

FDADec 9, 2016FL• O'Pelle Enterprises, Inc.

Opelle Bakery Egg Bagel (O'Pelle) – Undeclared Yellow 5 (2016)

The Egg Bagel flavor lacks declaration of Yellow 5 on its label.

Class IIModerate

FDADec 9, 2016FL• O'Pelle Enterprises, Inc.

Lipotropic Blend (Tri-Coast Pharmacy) – sterility concern (2016)

Lack of Assurance of Sterility

Class IIModerate

FDANov 17, 2016Nationwide• Tri-Coast Pharmacy

Calcium Gluconate Injection (Tri-Coast Pharmacy) – sterility risk (2016)

Lack of Assurance of Sterility

Class IIModerate

FDANov 17, 2016Nationwide• Tri-Coast Pharmacy

BiMix Phentolamine/Papaverine (Tri-Coast) – sterility concern (2016)

Lack of Assurance of Sterility

Class IIModerate

FDANov 17, 2016Nationwide• Tri-Coast Pharmacy

Infuvite IV (Tri-Coast) – sterility concern (2016)

Lack of Assurance of Sterility

Class IIModerate

FDANov 17, 2016Nationwide• Tri-Coast Pharmacy

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