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Showing 461–480 of 1571 results

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

Presence of Particulate Matter

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

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

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

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

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

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

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.

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.

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

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

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

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

Atomoxetine 80mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine 80mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine 100mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine Capsules 40mg (Glenmark) – Impurity Risk (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine 10mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine 25mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

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