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Showing 181–200 of 1310 results

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RECOMBINATE Antihemophilic Factor (Cardinal Health) – Temperature Deviation (2025)

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

Class IIModerate

FDAJul 30, 2025Nationwide• Cardinal Health Inc.

Xolair Injection (Cardinal Health) - Temperature Exposure (2025)

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

Class IIModerate

FDAJul 30, 2025Nationwide• Cardinal Health Inc.

Sodium Bicarbonate Injection (Exela Pharma) – Arsenic Impurities (2025)

Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.

Class IIModerate

FDAJul 30, 2025Nationwide• Exela Pharma Sciences LLC

Sucralfate Tablets (Amerisource) – Quality Monitoring Failure (2025)

CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

Class IIModerate

FDAJul 29, 2025Nationwide• Amerisource Health Services LLC

Levoxyl Levothyroxine (Pfizer) – Subpotent Drug (2025)

Subpotent drug

Class IIModerate

FDAJul 29, 2025Nationwide• Pfizer

Doxepin Hydrochloride Capsules (Alembic) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Class IIModerate

FDAJul 25, 2025Nationwide• Alembic Pharmaceuticals Limited

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Class IIModerate

FDAJul 25, 2025AZ, IN, NJ• Breckenridge Pharmaceutical, Inc.

Whole Wheat Chocolate Croissants (Bonami Baking) – undeclared milk soy (2025)

Undeclared Milk

Undeclared milk and soy (from soy lecithin) from sub-ingredients.

Class IIModerate

FDAJul 24, 2025CA• The Bonami Baking Company, Inc.

Whole Grain Jalapeno Bagel (Bonami Baking) – undeclared milk (2025)

Undeclared Milk

Undeclared milk from Contains statement.

Class IIModerate

FDAJul 24, 2025CA• The Bonami Baking Company, Inc.

Wheat Hamburger Buns (Bonami Baking) – Undeclared Allergens (2025)

Undeclared Milk

Undeclared milk and/or eggs from sub-ingredients and/or Contains statement.

Class IIModerate

FDAJul 24, 2025CA• The Bonami Baking Company, Inc.

Lorazepam Injection (Hikma) – Compound Impurities (2025)

Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds

Class IIModerate

FDAJul 22, 2025Nationwide• Hikma Pharmaceuticals USA Inc.

Belsomra Tablets (Merck) – Dissolution Performance (2025)

Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.

Class IIModerate

FDAJul 21, 2025Nationwide• Merck & Co. Inc

Quick Touch Alcohol Prep Pads (Yangzhou Yulou) – Manufacturing Deviation (2025)

cGMP Deviations

Class IIModerate

FDAJul 21, 2025Nationwide• YANGZHOU YULOU PAPER PRODUCTS CO., LTD

Amlodipine Olmesartan Tablets (Ascend) – Dissolution Failure (2025)

Failed Dissolution Specifications: low dissolution results

Class IIModerate

FDAJul 21, 2025Nationwide• Ascend Laboratories, LLC

Duloxetine Capsules (Breckenridge Pharmaceutical) – Impurity Concern (2025)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit

Class IIModerate

FDAJul 15, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Sucralfate Tablets (Nostrum Laboratories) – Quality Program Disruption (2025)

CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

Class IIModerate

FDAJul 11, 2025Nationwide• Nostrum Laboratories, Inc.

Bicillin L-A Injection (Pfizer) – Particulate Inspection Problem (2025)

CGMP Deviations; particulates identified during visual inspection

Class IIModerate

FDAJul 10, 2025Nationwide• Pfizer Inc.

Bicillin L-A Injection (Pfizer) – Particulate Inspection Problem (2025)

CGMP Deviations; particulates identified during visual inspection

Class IIModerate

FDAJul 10, 2025Nationwide• Pfizer Inc.

Epinephrine Lidocaine HCL (Imprimis NJOF) – Sub-Potent Drug (2025)

Sub-Potent Drug: Subpotent assay results during stability testing.

Class IIModerate

FDAJul 9, 2025Nationwide• Imprimis NJOF, LLC

Cinacalcet Tablets 90mg (Strides Pharma) – Failed Dissolution (2025)

Failed Dissolution Specifications.

Class IIModerate

FDAJul 9, 2025Nationwide• Strides Pharma, Inc.

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