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Showing 1181–1200 of 14370 results

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HydrALAZINE Hydrochloride Tablets (Amerisource) – impurity specification (2023)

Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.

FDASep 1, 2023Nationwide• Amerisource Health Services LLC

TRP Natural Eyes Eye Lid Relief (Amman Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDASep 1, 2023CO, IN, RI• AMMAN PHARMACEUTICAL INDUSTRIES

TRP Natural Eyes Twitching Relief (Amman Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDASep 1, 2023CO, IN, RI• AMMAN PHARMACEUTICAL INDUSTRIES

LubriFresh PM Nighttime Eye Ointment (Amman Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDASep 1, 2023CO, IN, RI• AMMAN PHARMACEUTICAL INDUSTRIES

TRP Natural Eyes Stye Relief (Amman Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDASep 1, 2023CO, IN, RI• AMMAN PHARMACEUTICAL INDUSTRIES

Sucralfate Oral Suspension (VistaPharm) – potency specification (2023)

Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results

Class IIModerate

FDAAug 30, 2023Nationwide• VistaPharm LLC

Digoxin Tablets 0.25mg (Marlex) – Label Mix-Up (2023)

Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.

Class IIModerate

FDAAug 25, 2023Nationwide• Marlex Pharmaceuticals, Inc.

WEFUN Capsules (Wefun) – Undeclared Ingredient (2023)

Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.

FDAAug 25, 2023Nationwide• Hua Da Trading, Inc. dba Wefun Inc.

Digoxin Tablets 0.125mg (Marlex) – Label Mix-Up (2023)

Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.

FDAAug 25, 2023Nationwide• Marlex Pharmaceuticals, Inc.

Doxil Injection (Baxter) – Temperature Exposure (2023)

CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.

Class IIModerate

FDAAug 24, 2023Nationwide• Baxter Healthcare Corporation

Clindamycin Phosphate Solution (Contract Pharma) – Leaking Container (2023)

Defective Container: slow leakage under the cap

FDAAug 23, 2023Nationwide• Contract Pharmaceuticals Limited Canada

Fenugreek Capsules (Vitality Works) – Foreign Material (2023)

Foreign material: pieces of a pen (writing utensil).

Class IIModerate

FDAAug 22, 2023Nationwide• Vitality Works, Inc

Fenugreek Capsules (Vitality Works) – Foreign material risk (2023)

Foreign material: pieces of a pen (writing utensil).

Class IIModerate

FDAAug 22, 2023Nationwide• Vitality Works, Inc

Fenugreek Capsules (Vitality Works) – Foreign material pen (2023)

Foreign material: pieces of a pen (writing utensil).

Class IIModerate

FDAAug 22, 2023Nationwide• Vitality Works, Inc

Fenugreek Capsules (Vitality Works) – Pen Fragments (2023)

Foreign material: pieces of a pen (writing utensil).

Class IIModerate

FDAAug 22, 2023Nationwide• Vitality Works, Inc

Fenugreek Capsules (Vitality Works) – Pen Fragment (2023)

Foreign material: pieces of a pen (writing utensil).

Class IIModerate

FDAAug 22, 2023Nationwide• Vitality Works, Inc

Fenugreek Capsules (Vitality Works) – Foreign Material (2023)

Foreign material: pieces of a pen (writing utensil).

Class IIModerate

FDAAug 22, 2023Nationwide• Vitality Works, Inc

Fenugreek Capsules (Vitality Works) – Foreign Material (2023)

Foreign material: pieces of a pen (writing utensil).

Class IIModerate

FDAAug 22, 2023Nationwide• Vitality Works, Inc

Fenugreek Capsules (Vitality Works) – Foreign material pen (2023)

Foreign material: pieces of a pen (writing utensil).

Class IIModerate

FDAAug 22, 2023Nationwide• Vitality Works, Inc

Fenugreek Capsules (Vitality Works) – Pen Fragment (2023)

Foreign material: pieces of a pen (writing utensil).

Class IIModerate

FDAAug 22, 2023Nationwide• Vitality Works, Inc

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