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Showing 4721–4740 of 11714 results

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VICRYL Suture (Ethicon) – Packaging Sterility (2024)

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

FDAMay 10, 2024Nationwide• Ethicon, Inc.

MONOCRYL Suture (Ethicon) – Packaging Sterility (2024)

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

FDAMay 10, 2024Nationwide• Ethicon, Inc.

Aahu Barah Apricot Roll (Global Commodities) – Elevated Sulfites (2024)

Undeclared Allergen

Product contains elevated levels of undeclared sulfites.

Class IHigh

FDAMay 10, 2024MD, MO, NY +3 more• Global Commodities Inc

Cephalexin Suspension 250mg (Bryant Ranch) – Incorrect Labeling (2024)

Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'

FDAMay 10, 2024Nationwide• Bryant Ranch Prepack, Inc.

Rizatriptan Benzoate Tablets (Glenmark) – Nitrosamine Impurity (2024)

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

Class IIModerate

FDAMay 10, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Duloxetine Capsules (Preferred) – Nitrosamine Contamination (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Class IIModerate

FDAMay 10, 2024CA, CT, FL +2 more• Preferred Pharmaceuticals, Inc.

Cephalexin Suspension 250mg (Bryant Ranch) – Incorrect Labeling (2024)

Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'

FDAMay 10, 2024Nationwide• Bryant Ranch Prepack, Inc.

Rizatriptan Benzoate Tablets (Glenmark) – Nitrosamine Impurity (2024)

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

Class IIModerate

FDAMay 10, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Cephalexin Suspension 125mg (Bryant Ranch) – Incorrect Labeling (2024)

Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'

FDAMay 10, 2024Nationwide• Bryant Ranch Prepack, Inc.

Cephalexin Suspension 250mg (Bryant Ranch) – Incorrect Labeling (2024)

Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'

FDAMay 10, 2024Nationwide• Bryant Ranch Prepack, Inc.

Cephalexin Suspension 125mg (Bryant Ranch) – Incorrect Labeling (2024)

Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g

FDAMay 10, 2024Nationwide• Bryant Ranch Prepack, Inc.

BW Lasso Diagnostic EP Catheter (Stryker) – Testing Requirements (2024)

Diagnostic electrophysiology (EP) catheters do not meet testing requirements.

FDAMay 10, 2024Nationwide• Stryker Sustainability Solutions

Kosmos iOS Ultrasound (Echonous) – Measurement Inaccuracy (2024)

Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd party software, such as PACS or other post-processing software, which may lead to inaccurate diagnoses or treatment.

FDAMay 9, 2024AL, AK, AZ +29 more• Echonous Inc

Fixed Needle Syringes (Sol-Millennium) – 510(k) Modification (2024)

Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.

FDAMay 9, 2024Nationwide• Sol-Millennium Medical Inc.

Exchangeable Needle Syringes (Sol-Millennium) – 510(k) Modification (2024)

Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.

FDAMay 9, 2024Nationwide• Sol-Millennium Medical Inc.

Low Dead Space Syringes (Sol-Millennium) – 510(k) Modification (2024)

Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.

FDAMay 9, 2024Nationwide• Sol-Millennium Medical Inc.

Hoffman LRF Wire Tensioner (Stryker) – Adjustment Ring Issue (2024)

The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.

FDAMay 9, 2024Nationwide• Stryker GmbH Bohnackerweg 1 Selzach Switzerland

First Source iQ Flex M Cart (First Source) – Positioning Arm Risk (2024)

Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.

FDAMay 9, 2024Nationwide• First Source Inc

Eccentric Tip Syringes (Sol-Millennium) – 510(k) Modification (2024)

Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.

FDAMay 9, 2024Nationwide• Sol-Millennium Medical Inc.

Luer Slip Tip Syringes (Sol-Millennium) – 510(k) Modification (2024)

Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.

FDAMay 9, 2024Nationwide• Sol-Millennium Medical Inc.

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