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Showing 501–520 of 14362 results

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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

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.

Class IHigh

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

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

Class IHigh

FDAFeb 13, 2025Nationwide• ICU Medical, Inc.

Sodium Chloride Injection (Nephron) – Potential Leakage (2025)

Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.

Class IIModerate

FDAFeb 10, 2025Nationwide• Nephron Sterile Compounding Center LLC

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

Failed Dissolution Specifications

Class IIModerate

FDAFeb 6, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Estradiol Gel (Padagis) – Unsealed Packets (2025)

Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.

Class IIModerate

FDAFeb 6, 2025Nationwide• Padagis US LLC

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.

Class IHigh

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