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Showing 461–480 of 505 results

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Duloxetine Capsules 20mg (Breckenridge) – Nitrosamine Impurity (2025)

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

Class IIModerate

FDAFeb 28, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Neupogen 480mcg (Amgen) – Stability Expiration Issue (2025)

Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.

Class IIModerate

FDAFeb 27, 2025Nationwide• Amgen, Inc.

Neupogen 300mcg (Amgen) – Stability Expiration Issue (2025)

Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.

Class IIModerate

FDAFeb 27, 2025Nationwide• Amgen, Inc.

Metformin Extended-Release 500mg (A-S Medication) – Foreign Tablets (2025)

Presence of Foreign Tablets/Capsules.

Class IIModerate

FDAFeb 25, 2025Nationwide• A-S Medication Solutions LLC

Prasugrel Tablets 5mg (Mylan) – Dissolution Failure (2025)

Failed Dissolution Specifications - low dissolution results

Class IIModerate

FDAFeb 25, 2025Nationwide• MYLAN PHARMACEUTICALS INC

Phenylephrine Sodium Chloride (Central Admixture) – Particulate Matter (2025)

Presence of Particulate Matter

FDAFeb 20, 2025Nationwide• Central Admixture Pharmacy Services, Inc.

Vitality Enhancement (One Source) – Undeclared Ingredients (2025)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.

FDAFeb 20, 2025Nationwide• One Source Nutrition, Inc,

Morphine Sulfate Syringe (Safecor Health) – Leakage Risk (2025)

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Class IIModerate

FDAFeb 17, 2025Nationwide• Safecor Health, LLC

Ferrous Sulfate Syringe (Safecor Health) – Leakage Risk (2025)

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Class IIModerate

FDAFeb 17, 2025Nationwide• Safecor Health, LLC

Vitamin D Supplement (Safecor Health) – Leakage Risk (2025)

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Class IIModerate

FDAFeb 17, 2025Nationwide• Safecor Health, LLC

Lorazepam Oral Syringe (Safecor Health) – Leakage Risk (2025)

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Class IIModerate

FDAFeb 17, 2025Nationwide• Safecor Health, LLC

Potassium Chloride Injection (ICU Medical) – Labeling Error (2025)

Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq

FDAFeb 13, 2025Nationwide• ICU Medical, Inc.

Potassium Chloride Injection (ICU Medical) – Labeling Error (2025)

Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.

FDAFeb 13, 2025Nationwide• ICU Medical, Inc.

Nelarabine Injection (Zydus) – Impurity Specifications (2025)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAFeb 13, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Nelarabine Injection (Zydus) – Impurity Specifications (2025)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAFeb 13, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Morphine Sulfate Tablets (Sun Pharma) – Dissolution Failure (2025)

Failed Dissolution Specifications

Class IIModerate

FDAFeb 6, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Silodosin Capsules (AvKARE) – Subpotent Drug (2025)

Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)

Class IIModerate

FDAFeb 4, 2025Nationwide• AvKARE

Fentanyl Patch (Alvogen) – Defective Delivery System (2025)

Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.

FDAJan 31, 2025Nationwide• Alvogen, Inc

Ciprofloxacin Ophth Solution (Direct Rx) – Bottle Defect (2025)

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

Class IIModerate

FDAJan 31, 2025AL, CA, FL +3 more• Direct Rx

Potassium Chloride Tablets (Harvard Drug) – Dissolution Failure (2025)

Failed Dissolution Specifications.

Class IIModerate

FDAJan 30, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

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