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Simvastatin 20mg Tablets (Direct Rx) – cGMP Quality Issues (2023)

cGMP deviations

Class IIModerate

FDAMar 13, 2023Nationwide• Direct Rx

Ropinirole 0.25mg Tablets (Direct Rx) – cGMP Quality Issues (2023)

cGMP deviations

Class IIModerate

FDAMar 13, 2023Nationwide• Direct Rx

Glimepiride 4mg Tablets (Direct Rx) – cGMP Quality Issues (2023)

cGMP deviations

Class IIModerate

FDAMar 13, 2023Nationwide• Direct Rx

Montelukast Sodium 10mg Tablets (Direct Rx) – cGMP Quality Issues (2023)

cGMP deviations

Class IIModerate

FDAMar 13, 2023Nationwide• Direct Rx

Simvastatin Tablets (Direct Rx) – Manufacturing Deviation (2023)

cGMP deviations

Class IIModerate

FDAMar 13, 2023Nationwide• Direct Rx

Glimepiride 1mg Tablets (Direct Rx) – cGMP Quality Issues (2023)

cGMP deviations

Class IIModerate

FDAMar 13, 2023Nationwide• Direct Rx

Simvastatin Tablets (Direct Rx) – Manufacturing Deviation (2023)

cGMP deviations

Class IIModerate

FDAMar 13, 2023Nationwide• Direct Rx

Finasteride 5mg Tablets (Direct Rx) – cGMP Quality Issues (2023)

cGMP deviations

Class IIModerate

FDAMar 13, 2023Nationwide• Direct Rx

Simvastatin 10mg Tablets (Direct Rx) – cGMP Quality Issues (2023)

cGMP deviations

Class IIModerate

FDAMar 13, 2023Nationwide• Direct Rx

Matiz Piparra Peppers (Culinary Collective) - Glass Shard (2023)

A shard of glass being found in one of the jars.

Class IIModerate

FDAMar 13, 2023IL, IN, IA +4 more• Power Selles Imports dba Culinary Collective

Glimepiride 2mg Tablets (Direct Rx) – cGMP Quality Issues (2023)

cGMP deviations

Class IIModerate

FDAMar 13, 2023Nationwide• Direct Rx

Ropinirole Tablets (Direct Rx) – Manufacturing Deviation (2023)

cGMP deviations

Class IIModerate

FDAMar 13, 2023Nationwide• Direct Rx

Daytrana 10mg Patch (Noven) – Delivery System Defect (2023)

Defective Delivery System: Out of specification for shear.

Class IIModerate

FDAMar 10, 2023Nationwide• Noven Pharmaceuticals Inc

Daytrana 15mg Patch (Noven) – Delivery System Defect (2023)

Defective Delivery System: Out of specification for shear.

Class IIModerate

FDAMar 10, 2023Nationwide• Noven Pharmaceuticals Inc

Daytrana 30mg Patch (Noven) – Delivery System Defect (2023)

Defective Delivery System: Out of specification for shear.

Class IIModerate

FDAMar 10, 2023Nationwide• Noven Pharmaceuticals Inc

Daytrana 20mg Patch (Noven) – Delivery System Defect (2023)

Defective Delivery System: Out of specification for shear.

Class IIModerate

FDAMar 10, 2023Nationwide• Noven Pharmaceuticals Inc

Purity Acidophilus Milk (DFA Dairy) - Sanitizer Contamination (2023)

1% Low Fat Milk potentially contaminated with sanitizer

Class IIModerate

FDAMar 10, 2023AL• DFA Dairy Brands Fluid, LLC

Jardiance 25mg Tablets (Boehringer) – Label Mix-up (2023)

Labeling: Label Mix-up

Class IIModerate

FDAMar 9, 2023Nationwide• Boehringer Ingelheim Pharmaceuticals, Inc.

Sofrito Marinating Sauce (20-100 Seasoning) - Improper Storage (2023)

Product was not stored refrigerated.

Class IIModerate

FDAMar 9, 2023Nationwide• 20-100 Delicious Seasoning LLC

Silver Solution Supplement - Misleading COVID Claims (2023)

Product labeled and intended to mitigate, prevent, or treat COVID-19

Class IIModerate

FDAMar 7, 2023Nationwide• Natural Solutions Foundation

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