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White Hot Dog Enriched Buns (Perfection Bakeries) – Undeclared Sesame (2023)

Undeclared Allergen

undeclared sesame

Class IIModerate

FDAMar 21, 2023IL, IN, MI +1 more• Perfection Bakeries LLC

Choconut Breakfast Cookie (Bakery 37) – Undeclared Sesame (2023)

Sesame is declared in the Ingredients statement but it is not declared in the Contains statement.

Class IIModerate

FDAMar 21, 2023IN, OR• Bakery 37 Inc

Legendary Breakfast Cookie (Bakery 37) – Undeclared Sesame (2023)

Undeclared Allergen

Undeclared sesame in cookies

Class IIModerate

FDAMar 21, 2023IN, OR• Bakery 37 Inc

Aripiprazole 5mg Tablets (RemedyRepack) – Manufacturing Deviation (2023)

cGMP Deviations

Class IIModerate

FDAMar 20, 2023Nationwide• RemedyRepack Inc.

Doxazosin 2mg Tablets (RemedyRepack) – Manufacturing Deviation (2023)

cGMP Deviations

Class IIModerate

FDAMar 20, 2023Nationwide• RemedyRepack Inc.

Atorvastatin 20mg Tablets (RemedyRepack) – Manufacturing Deviation (2023)

cGMP Deviations

Class IIModerate

FDAMar 20, 2023Nationwide• RemedyRepack Inc.

Rosuvastatin 10mg Tablets (RemedyRepack) – Manufacturing Deviation (2023)

cGMP Deviations

Class IIModerate

FDAMar 20, 2023Nationwide• RemedyRepack Inc.

Simvastatin 10mg Tablets (RemedyRepack) – Manufacturing Deviation (2023)

cGMP Deviations

Class IIModerate

FDAMar 20, 2023Nationwide• RemedyRepack Inc.

Ropinirole 0.5mg Tablets (RemedyRepack) – Manufacturing Deviation (2023)

cGMP Deviations

Class IIModerate

FDAMar 20, 2023Nationwide• RemedyRepack Inc.

Rosuvastatin 5mg Tablets (RemedyRepack) – Manufacturing Deviation (2023)

cGMP Deviations

Class IIModerate

FDAMar 20, 2023Nationwide• RemedyRepack Inc.

Glimepiride 2mg Tablets (RemedyRepack) – Manufacturing Deviation (2023)

cGMP Deviations

Class IIModerate

FDAMar 20, 2023Nationwide• RemedyRepack Inc.

Rosuvastatin 40mg Tablets (RemedyRepack) – Manufacturing Deviation (2023)

cGMP Deviations

Class IIModerate

FDAMar 20, 2023Nationwide• RemedyRepack Inc.

Atorvastatin 10mg Tablets (RemedyRepack) – Manufacturing Deviation (2023)

cGMP Deviations

Class IIModerate

FDAMar 20, 2023Nationwide• RemedyRepack Inc.

Ropinirole 2mg Tablets (RemedyRepack) – Manufacturing Deviation (2023)

cGMP Deviations

Class IIModerate

FDAMar 20, 2023Nationwide• RemedyRepack Inc.

Rosuvastatin 5mg Tablets (RemedyRepack) – Manufacturing Deviation (2023)

cGMP Deviations

Class IIModerate

FDAMar 20, 2023Nationwide• RemedyRepack Inc.

Tadalafil 5mg Tablets (RemedyRepack) – Manufacturing Deviation (2023)

cGMP Deviations

Class IIModerate

FDAMar 20, 2023Nationwide• RemedyRepack Inc.

Simvastatin 40mg Tablets (RemedyRepack) – Manufacturing Deviation (2023)

cGMP Deviations

Class IIModerate

FDAMar 20, 2023Nationwide• RemedyRepack Inc.

Aripiprazole Tablets (Ascend Laboratories) – Spectroscopic Test Failure (2023)

Out of specification (OOS) for Spectroscopic Identification test by IR.

Class IIModerate

FDAMar 17, 2023Nationwide• Ascend Laboratories, LLC

Glimepiride 4mg Tablets (Amerisource) – Manufacturing Deviation (2023)

CGMP Deviations: recalling drug products following an FDA inspection.

Class IIModerate

FDAMar 17, 2023Nationwide• Amerisource Health Services LLC

Glimepiride Tablets (Amerisource Health Services) – Manufacturing Deviation (2023)

CGMP Deviations: recalling drug products following an FDA inspection.

Class IIModerate

FDAMar 17, 2023Nationwide• Amerisource Health Services LLC

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