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Showing 2021–2040 of 29086 results

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H-E-B Creamy Creations Chocolate Ice Cream (H-E-B) – Metal Contamination (2024)

Potential metal contamination

Class IIModerate

FDAApr 27, 2024TX• H-E-B San Antonio Retail Support Center (SARSC)

H-E-B Creamy Creations Homemade Ice Cream (H-E-B) – Metal Contamination (2024)

Potential metal contamination

Class IIModerate

FDAApr 27, 2024TX• H-E-B San Antonio Retail Support Center (SARSC)

H-E-B Creamy Creations Lime/Orange Ice Cream (H-E-B) – Metal Contamination (2024)

Potential metal contamination

Class IIModerate

FDAApr 27, 2024TX• H-E-B San Antonio Retail Support Center (SARSC)

Tramadol Tablets (Rubicon) – Foreign Tablet Presence (2024)

Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol

Class IIModerate

FDAApr 26, 2024Nationwide• Rubicon Research Private Limited

YoCrunch Vanilla Yogurt with M&Ms (Danone) – Undeclared Wheat (2024)

Undeclared Gluten

Undeclared wheat

Class IIModerate

FDAApr 26, 2024FL, IN• DANONE US LLC

Jamai Bou Chadni Hot Mix Chanachur (CK Food) – Undeclared Peanuts (2024)

Undeclared Nuts

Visible undeclared peanuts

Class IIModerate

FDAApr 26, 2024MI, NY, OH• CK FOOD INC

Timolol Maleate Solution (FDC) – Defective Container (2024)

Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.

Class IIModerate

FDAApr 25, 2024NJ• FDC Limited

Methylprednisolone Injection (Sagent) – Particulate Matter (2024)

Presence of Particulate Matter: Potential for black particulates in the drug product.

Class IIModerate

FDAApr 25, 2024Nationwide• Sagent Pharmaceuticals

Wegman's Half Loaf Garlic Bread (Wegmans Food Markets, Inc.) – undeclared milk (2024)

Undeclared Milk

Contains undeclared milk

Class IIModerate

FDAApr 25, 2024NY, PA• Wegmans Food Markets, Inc.

Crustless Chicken Potato Pot Pie (Nutrition Corp) – Listeria Risk (2024)

Possible contamination with Listeria monocytogenes

Class IIModerate

FDAApr 25, 2024Nationwide• Nutrition Corp

Haloperidol Injection (Somerset) – Foreign Substance (2024)

Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).

Class IIModerate

FDAApr 24, 2024Nationwide• SOMERSET THERAPEUTICS LLC

Clorazepate Tablets (Aurobindo) – Tablet Discoloration (2024)

Discoloration: Dotted and yellow spots on tablets

Class IIModerate

FDAApr 24, 2024Nationwide• Aurobindo Pharma USA Inc.

Progesterone Tablets (Anazao) – Metal Fragment (2024)

Presence of Foreign Substance; Broken metal piece found embedded in tablet.

Class IIModerate

FDAApr 24, 2024Nationwide• Coast Quality Pharmacy, LLC dba Anazao Health

Cefdinir Suspension (Lupin) – Foreign Material (2024)

Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

Class IIModerate

FDAApr 24, 2024Nationwide• Lupin Pharmaceuticals Inc.

Clorazepate Tablets (Aurobindo) – Tablet Discoloration (2024)

Discoloration: Dotted and yellow spots on tablets

Class IIModerate

FDAApr 24, 2024Nationwide• Aurobindo Pharma USA Inc.

Cefdinir Suspension (Lupin) – Foreign Material (2024)

Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

Class IIModerate

FDAApr 24, 2024Nationwide• Lupin Pharmaceuticals Inc.

Minolira Tablets (EPI) – Quality Program Discontinuation (2024)

CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

Class IIModerate

FDAApr 23, 2024Nationwide• EPI Health, LLC

Cloderm Cream (EPI) – Quality Program Discontinuation (2024)

CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

Class IIModerate

FDAApr 23, 2024Nationwide• EPI Health, LLC

Minolira (EPI Health) – Quality Program Deviation (2024)

CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

Class IIModerate

FDAApr 23, 2024Nationwide• EPI Health, LLC

EYLEA Injection (Regeneron) – Syringe Breakage (2024)

Lack of Assurance of Sterility: Complaints of syringe breakage

Class IIModerate

FDAApr 23, 2024Nationwide• Regeneron Pharmaceuticals Inc

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