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Showing 361–380 of 3363 results

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Bendamustine HCl Injection (Baxter) – labeling issue (2023)

Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.

FDAAug 14, 2023Nationwide• Baxter Healthcare Corporation

Milrinone Lactate Injection (Caplin) – impurity specification (2023)

Failed Impurities/Degradation Specifications

FDAAug 14, 2023Nationwide• Caplin Steriles Limited

Trandolapril/Verapamil Tablets (Glenmark) – subpotent medication (2023)

Subpotent: Out of Specification for Assay Test at the 3-month time point.

Class IIILow

FDAAug 14, 2023Nationwide• Glenmark Pharmaceuticals Inc., USA

Pasteurized Prepared Cheese Product (Great Lakes Cheese) – refrigeration issue (2023)

Refrigerated pasteurized process cheese products may not be refrigerated at customer level due to labeled refrigeration requirements varying on finished product labels.

FDAAug 11, 2023AL, AZ, CA +29 more• Great Lakes Cheese, Inc.

Easy Melt Cheese (Great Lakes Cheese) – Refrigeration Issue (2023)

Refrigerated pasteurized process cheese products may not be refrigerated at customer level due to labeled refrigeration requirements varying on finished product labels.

FDAAug 11, 2023AL, AZ, CA +29 more• Great Lakes Cheese, Inc.

Salsa Roja (Twin Cities Co-Op) – Temperature Deviation (2023)

Dips and sauces received out of temperature specifications. Product was not quarantined; product was shipped to customers.

FDAAug 11, 2023IA, MI, MN +1 more• Twin Cities Co-Op Partners Inc.

Cheese Spread (Great Lakes Cheese) – Refrigeration Issue (2023)

Refrigerated pasteurized process cheese products may not be refrigerated at customer level due to labeled refrigeration requirements varying on finished product labels.

FDAAug 11, 2023AL, AZ, CA +29 more• Great Lakes Cheese, Inc.

Melt'n Cheese (Great Lakes Cheese) – Refrigeration Issue (2023)

Refrigerated pasteurized process cheese products may not be refrigerated at customer level due to labeled refrigeration requirements varying on finished product labels.

FDAAug 11, 2023AL, AZ, CA +29 more• Great Lakes Cheese, Inc.

Melt'n Dip Cheese (Great Lakes Cheese) – Refrigeration Issue (2023)

Refrigerated pasteurized process cheese products may not be refrigerated at customer level due to labeled refrigeration requirements varying on finished product labels.

FDAAug 11, 2023AL, AZ, CA +29 more• Great Lakes Cheese, Inc.

Cheese Product (Great Lakes Cheese) – Refrigeration Issue (2023)

Refrigerated pasteurized process cheese products may not be refrigerated at customer level due to labeled refrigeration requirements varying on finished product labels.

FDAAug 11, 2023AL, AZ, CA +29 more• Great Lakes Cheese, Inc.

Cheese Spread (Great Lakes Cheese) – Refrigeration Issue (2023)

Refrigerated pasteurized process cheese products may not be refrigerated at customer level due to labeled refrigeration requirements varying on finished product labels.

FDAAug 11, 2023AL, AZ, CA +29 more• Great Lakes Cheese, Inc.

Diablo Salsa (Twin Cities Co-Op) – Temperature Deviation (2023)

Dips and sauces received out of temperature specifications. Product was not quarantined; product was shipped to customers.

FDAAug 11, 2023IA, MI, MN +1 more• Twin Cities Co-Op Partners Inc.

Queso Blanco (Great Lakes Cheese) – Refrigeration Issue (2023)

Refrigerated pasteurized process cheese products may not be refrigerated at customer level due to labeled refrigeration requirements varying on finished product labels.

FDAAug 11, 2023AL, AZ, CA +29 more• Great Lakes Cheese, Inc.

Cheese Spread (Great Lakes Cheese) – Refrigeration Issue (2023)

Refrigerated pasteurized process cheese products may not be refrigerated at customer level due to labeled refrigeration requirements varying on finished product labels.

FDAAug 11, 2023AL, AZ, CA +29 more• Great Lakes Cheese, Inc.

La Reyna Queso Dip (Twin Cities Co-Op) – temperature deviation (2023)

Dips and sauces received out of temperature specifications. Product was not quarantined; product was shipped to customers.

FDAAug 11, 2023IA, MI, MN +1 more• Twin Cities Co-Op Partners Inc.

Easy Melt Salsa Queso (Great Lakes Cheese) – Refrigeration Issue (2023)

Refrigerated pasteurized process cheese products may not be refrigerated at customer level due to labeled refrigeration requirements varying on finished product labels.

FDAAug 11, 2023AL, AZ, CA +29 more• Great Lakes Cheese, Inc.

Salsa Verde (Twin Cities Co-Op) – Temperature Deviation (2023)

Dips and sauces received out of temperature specifications. Product was not quarantined; product was shipped to customers.

FDAAug 11, 2023IA, MI, MN +1 more• Twin Cities Co-Op Partners Inc.

Harris Tetter Cheesy Melt (Great Lakes Cheese) – refrigeration issue (2023)

Refrigerated pasteurized process cheese products may not be refrigerated at customer level due to labeled refrigeration requirements varying on finished product labels.

FDAAug 11, 2023AL, AZ, CA +29 more• Great Lakes Cheese, Inc.

La Reyna Guacamole (Twin Cities Co-Op) – temperature deviation (2023)

Dips and sauces received out of temperature specifications. Product was not quarantined; product was shipped to customers.

FDAAug 11, 2023IA, MI, MN +1 more• Twin Cities Co-Op Partners Inc.

Moxifloxacin-Bromfenac Solution (Imprimis) – sub-potent drug (2023)

Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.

FDAAug 10, 2023Nationwide• Imprimis NJOF, LLC

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