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Showing 2921–2940 of 11714 results

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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.

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

Fentanyl Citrate (Fagron) – Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 31, 2025IN, PA• Fagron Compounding Services

Suction Tubing Connector (DeRoyal) – connection mismatch (2025)

Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plastic material, makes the assembly to a suction canister lid port difficult. This could result in inadequate suction and cause a delay in patient care.

FDAJan 31, 2025IL, MN, NC +2 more• DeRoyal Industries Inc

Beverage Base Sweet&Sour (OCBW) – Undeclared Yellow #5 (2025)

Undeclared Allergen

Undeclared Yellow #5

Class IIModerate

FDAJan 31, 2025AR, CA, CO +5 more• OCBW INC

Pipeline Vantage Embolization Device (Micro Therapeutics) – wall apposition issue (2025)

Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in females less-than-or-equal-to 45 years of age

FDAJan 30, 2025Nationwide• Micro Therapeutics, Inc.

Philips Connected Blood Glucose Meter (Telcare) – battery swelling (2025)

Telcare, LLC has received customer complaints related to battery expansion/swelling for its Philips Connected Blood Glucose Meter (i.e., BGM 4 brand name) Monitoring System.. The issue was identified by post market surveillance data (customer complaints) - events of battery expansion/swelling and associated symptoms, e.g., leading to the device's removable back cover (battery port) to separate. If there is a loss of primary function of the device due to the described device defect, an immediate health consequence that may result is prolonged hypoglycemia or hyperglycemia due to delay in treatment, as the blood glucose measurement is not available to guide treatment. In a worst-case situation, there is potential for battery swelling to result in explosion of the battery and/ or device. Exposure to explosion, and subsequently projectiles from the explosion, may result in several immediate health consequences, including concussion, headache, dizziness, eye irritation, blurred vision, eye injury, and vision impairment.

FDAJan 30, 2025Nationwide• Telcare, LLC

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

Leica CM1950 Cryostat (Leica) – firmware data loss (2025)

Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.

FDAJan 30, 2025Nationwide• LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany

CinchLock Flex Knotless Anchor (Stryker) – pullwire breakage (2025)

Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.

FDAJan 29, 2025Nationwide• Stryker Corporation

Medical Video Colonoscope (Pentax) – image visibility (2025)

During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.

FDAJan 29, 2025Nationwide• Pentax of America Inc

Medical Video Processor (Pentax) – image visibility (2025)

During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.

FDAJan 29, 2025Nationwide• Pentax of America Inc

Medical Upper GI Scope (Pentax) – image visibility (2025)

During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.

FDAJan 29, 2025Nationwide• Pentax of America Inc

Atomoxetine 10mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine Capsules 40mg (Glenmark) – Impurity Risk (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine 100mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine 80mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine 18mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine 25mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine 18mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

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