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Duloxetine Capsules (Breckenridge) – Impurity Limit Exceeded (2025)

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

FDANov 24, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

LifeShield Drug Library Management (DLM), LifeShield Infu... (ICU Medical, Inc.) – software issue only allows concentrat... (2025)

Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.

Moderate

FDANov 24, 2025Nationwide

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Duloxetine Capsules (Breckenridge) – Impurity Limit Exceeded (2025)

LifeShield Drug Library Management (DLM), LifeShield Infu... (ICU Medical, Inc.) – software issue only allows concentrat... (2025)

Decaf Coffee Pods (Gimme Coffee) – undeclared caffeine (2025)

Zimmer Air Dermatome, Model/Catalog Number: 00880100100 (Zimmer Surgical Inc) – the devices may have a misaligned thi... (2025)

Draeger Vapor 2000. Unheated, calibrated anesthetic vapor... (Draeger, Inc.) – a certain component of affected devic... (2025)

Draeger Vapor 3000. Unheated, calibrated anesthetic vapor... (Draeger, Inc.) – a certain component of affected devic... (2025)

BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fix... (Smith & Nephew, Inc.) – removal of affected lot of screws due... (2025)

LifeShield Drug Library Management (DLM); LifeShield Infu... (ICU Medical, Inc.) – for certain customers, the change sum... (2025)

Pecorino Romano Cheese (Wegmans) – listeria contamination (2025)

Pecan Cranberry Holiday Bark (Carousel Candies) – undeclared wheat (2025)

Senna Leaves (Whole Herb Company) – salmonella risk (2025)

Bisoprolol/Hydrochlorothiazide Tablets (Glenmark) – Cross Contamination (2025)

The Elecsys Anti-TSHR immunoassay is a three-step competi... (Roche Diagnostics Operations, Inc.) – issues identified: 1) results vary by... (2025)

Medline Hudson RCI Medium Concentration Oxygen Masks: ... – firm received multiple complaints reg... (2025)

Cookie Butter Holiday Bark (Carousel Candies) – undeclared pecan (2025)

Chocolate Chip Cookie Dough (Hudson River Foods) – Salmonella (2025)

Sinus Cap Herbal Supplement (A New Life Herbs) – misbranded (2025)

Chaga Mushroom Supplement (A New Life Herbs) – misbranded product (2025)

Ear Drops Herbal Supplement (A New Life Herbs) – misbranded product (2025)

Restore Clinician Programmer Application (CP App), Model ... (Medtronic Neuromodulation) – software issue where a device reset m... (2025)