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Showing 41–60 of 68218 results

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

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

Class IIModerate

FDANov 24, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

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

A certain component of affected devices was not delivered within specification and contained impurities.

FDANov 24, 2025Nationwide• Draeger, Inc.

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

A certain component of affected devices was not delivered within specification and contained impurities.

Moderate

FDANov 24, 2025Nationwide• Draeger, Inc.

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

Removal of affected lot of screws due to labeling error.

FDANov 24, 2025Nationwide• Smith & Nephew, Inc.

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

For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.

FDANov 24, 2025Nationwide• ICU Medical, 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.

FDANov 24, 2025Nationwide• ICU Medical, Inc.

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

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

Class IIModerate

FDANov 24, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Zen Cleanse Herbal Tea (Bell Industries) – salmonella risk (2025)

Potential Salmonella contamination

FDANov 24, 2025IN, MA, TX +1 more• Bell Industries LLC

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

Product may be contaminated with Listeria monocytogenes.

Class IVery High

FDANov 22, 2025CT, DE, MD +7 more• Wegmans Food Markets, Inc.

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

Undeclared Gluten

Undeclared wheat

FDANov 21, 2025Nationwide• Silvestri Sweets Inc dba Carousel Candies

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

Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortness of breath leading to hypoxia, which may require medical intervention to prevent further respiratory deterioration.

FDANov 21, 2025Nationwide

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

Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.

FDANov 21, 2025Nationwide• Roche Diagnostics Operations, Inc.

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

Undeclared Allergen

Undeclared pecan

FDANov 21, 2025Nationwide• Silvestri Sweets Inc dba Carousel Candies

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

Potential contamination with Salmonella.

FDANov 21, 2025CA, NJ• The Whole Herb Company, Inc.

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

Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe

Class IIIModerate

FDANov 21, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

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

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

FDANov 20, 2025AL, AZ, CA +9 more• A New Life Herbs, LLC

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

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

FDANov 20, 2025AL, AZ, CA +9 more• A New Life Herbs, LLC

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

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Class IIModerate

FDANov 20, 2025AL, AZ, CA +9 more• A New Life Herbs, LLC

Tropicamide Ophthalmic Solution (Fagron) – Incorrect Formulation (2025)

Incorrect Product Formulation

Class IIModerate

FDANov 20, 2025Nationwide• Fagron Compounding Services

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

Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.

FDANov 20, 2025Nationwide• Medtronic Neuromodulation

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