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Showing 741–760 of 2326 results

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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

Simethicone Oral Drops (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

Alcohol Prep Pads (Medline) – Subpotent Drug (2025)

Subpotent Drug

Class IIModerate

FDAFeb 17, 2025Nationwide• MEDLINE INDUSTRIES, LP - Northfield

Alcohol Prep Pads (Medline) – Subpotent Drug (2025)

Subpotent Drug

Class IIModerate

FDAFeb 17, 2025Nationwide• MEDLINE INDUSTRIES, LP - Northfield

Hot Ones Verde Sauce (Karma Sauce) – Plastic Contamination (2025)

Possible foreign object contamination (plastic).

Class IIModerate

FDAFeb 14, 2025IL, IN, NC +1 more• The Karma Sauce Company LLC

Hot Ones Rojo Sauce (Karma Sauce) – Plastic Contamination (2025)

Possible foreign object contamination (plastic).

Class IIModerate

FDAFeb 14, 2025IL, IN, NC +1 more• The Karma Sauce Company 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

Mineral Sunscreen (Babyganics) – Chemical Contamination (2025)

Chemical Contamination

Class IIModerate

FDAFeb 13, 2025Nationwide• Johnson, S C and Son, Inc

Mineral Sunscreen (Babyganics) – Chemical Contamination (2025)

Chemical Contamination

Class IIModerate

FDAFeb 13, 2025Nationwide• Johnson, S C and Son, Inc

Iodo Blanco Antiseptic (World Perfumes) – Container Defect (2025)

Defective Container: broken or leaking bottles.

Class IIModerate

FDAFeb 13, 2025FL• World Perfumes Inc.

Alcohol Prep Pads (ViaMed) – Sterility Concerns (2025)

Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.

Class IIModerate

FDAFeb 12, 2025FL• Wuxi Medical lnstrument Factory Co., Ltd.

Spinach Artichoke Dip (HEB) – Metal Inclusion (2025)

Potential metal inclusion

Class IIModerate

FDAFeb 9, 2025TX• HEB

Latanoprost (Aspen Biopharma) – CGMP Deviation (2025)

CGMP Deviations

Class IIModerate

FDAFeb 7, 2025FL, IN• Aspen Biopharma Labs Pvt., Ltd.

Chlorambucil (Aspen Biopharma) – CGMP Deviation (2025)

CGMP Deviations

Class IIModerate

FDAFeb 7, 2025FL, IN• Aspen Biopharma Labs Pvt., Ltd.

Finasteride (Aspen Biopharma) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

FDAFeb 7, 2025FL, IN• Aspen Biopharma Labs Pvt., Ltd.

Voriconazole (Aspen Biopharma) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

FDAFeb 7, 2025FL, IN• Aspen Biopharma Labs Pvt., Ltd.

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