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Showing 1661–1680 of 68218 results

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Tropicamide Ophthalmic Solution (Imprimis NJOF) – Potency Concern (2025)

Sub-Potent Drug: Subpotent assay results during stability testing.

FDAJul 9, 2025Nationwide• Imprimis NJOF, LLC

Rizatriptan Tablets (Ascend Laboratories) – Impurity Detection (2025)

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

Class IIModerate

FDAJul 9, 2025Nationwide• Ascend Laboratories, LLC

Epinephrine Lidocaine HCL (Imprimis NJOF) – Sub-Potent Drug (2025)

Sub-Potent Drug: Subpotent assay results during stability testing.

Class IIModerate

FDAJul 9, 2025Nationwide• Imprimis NJOF, LLC

Cinacalcet Tablets 90mg (Strides Pharma) – Failed Dissolution (2025)

Failed Dissolution Specifications.

Class IIModerate

FDAJul 9, 2025Nationwide• Strides Pharma, Inc.

Rizatriptan Benzoate Tablets (Ascend) – CGMP Impurity (2025)

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

Class IIModerate

FDAJul 9, 2025Nationwide• Ascend Laboratories, LLC

Semaglutide Injection (Boothwyn Pharmacy) – Subpotent Drug (2025)

Subpotent Drug

Class IIModerate

FDAJul 9, 2025Nationwide• Boothwyn Pharmacy LLC

Semaglutide Injection (Boothwyn Pharmacy) – Potency Issue (2025)

Subpotent Drug

Class IIModerate

FDAJul 9, 2025Nationwide• Boothwyn Pharmacy LLC

Ambu SPUR II (Ambu Inc.) – Manometer Port Blockage (2025)

Potential for the manometer port being blocked rendering the manometer non-functional.

FDAJul 9, 2025Nationwide• Ambu Inc.

Fluorescein 2% Ophth (Boothwyn Pharmacy) – Subpotent Drug (2025)

Subpotent Drug

FDAJul 9, 2025Nationwide• Boothwyn Pharmacy LLC

Vercise Brain Stimulation System (Boston Scientific) – Wire Break Risk (2025)

Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device removal/replacement and users may experience high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth connectivity challenges.

FDAJul 8, 2025Nationwide• Boston Scientific Neuromodulation Corporation

Burr Hole Cover Kit (Boston Scientific) – Clip Locking Problem (2025)

Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural delay, or lead-migration-which may require additional surgery.

FDAJul 8, 2025Nationwide• Boston Scientific Neuromodulation Corporation

BD Alaris Pump Module (CareFusion) – Infusion Flow Inaccuracy (2025)

Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

FDAJul 8, 2025Nationwide• CareFusion 303, Inc.

BD Alaris Pump Infusion Sets (CareFusion) – Flow Rate Issue (2025)

Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

FDAJul 8, 2025Nationwide• CareFusion 303, Inc.

Ritz Peanut Butter Cracker Sandwiches (Mondelez) – Undeclared Peanuts (2025)

Undeclared Allergen

Undeclared allergens (Peanut) due to mispackaging

Class IIModerate

FDAJul 8, 2025AL, AK, AZ +46 more• Mondelez Global Llc

Ritz Cracker Sandwiches (Mondelez) – Undeclared Peanuts (2025)

Undeclared Allergen

Undeclared allergens (Peanut) due to mispackaging

Class IIModerate

FDAJul 8, 2025AL, AK, AZ +46 more• Mondelez Global Llc

Sheehan Brothers Chili Cheese Coney – Undeclared Sesame (2025)

Undeclared Allergen

Undeclared sesame

FDAJul 8, 2025IN, KY, OH• SHEEHAN BROTHERS VENDING

Sheehan Brothers Spicy Chicken Sandwich – Undeclared Sesame (2025)

Undeclared Allergen

Undeclared sesame

FDAJul 8, 2025IN, KY, OH• SHEEHAN BROTHERS VENDING

Sheehan Brothers Cheeseburger – Undeclared Sesame (2025)

Undeclared Allergen

Undeclared sesame

FDAJul 8, 2025IN, KY, OH• SHEEHAN BROTHERS VENDING

BD Trucount Controls (BD Bio Sciences) – Incorrect SD Values (2025)

Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.

FDAJul 8, 2025Nationwide• Becton, Dickinson and Company, BD Bio Sciences

Medline General Surgery Tray (Medline) – Tourniquet Recall (2025)

Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential manufacturing defect in which the flange may detach from the bladder at the welded connection point. This detachment compromises the cuff's ability to maintain adequate air pressure, potentially resulting in tourniquet failure and increased risk of patient hemorrhaging.

FDAJul 8, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

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