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Showing 2701–2720 of 68218 results

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Hashbrown Patties (Lamb Weston) – Plastic Contamination (2025)

Approximately 1mm to 8 mm sized pieces of foreign material (plastic) found in product.

Class IIModerate

FDAApr 19, 2025AZ, HI, IN• LAMB WESTON Inc

Hashbrown Patties (Lamb Weston) – Plastic Contamination (2025)

Approximately 1mm to 8 mm sized pieces of foreign material (plastic) found in product.

Class IIModerate

FDAApr 19, 2025AZ, HI, IN• LAMB WESTON Inc

Hashbrown Patties (Lamb Weston) – Plastic Contamination (2025)

Approximately 1mm to 8 mm sized pieces of foreign material (plastic) found in product.

Class IIModerate

FDAApr 19, 2025AZ, HI, IN• LAMB WESTON Inc

Hashbrown Patties (Lamb Weston) – Plastic Contamination (2025)

Approximately 1mm to 8 mm sized pieces of foreign material (plastic) found in product.

Class IIModerate

FDAApr 19, 2025AZ, HI, IN• LAMB WESTON Inc

niCARdipine Hydrochloride Injection (American Regent) - Sterility Risk (2025)

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

Class IIModerate

FDAApr 18, 2025Nationwide• American Regent, Inc.

niCARdipine Hydrochloride Injection (American Regent) - Sterility Risk (2025)

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

Class IIModerate

FDAApr 18, 2025Nationwide• American Regent, Inc.

Clindamycin Hydrochloride Capsules (Preferred Pharmaceuticals) - CGMP Issues (2025)

cGMP Deviations

Class IIModerate

FDAApr 18, 2025Nationwide• Preferred Pharmaceuticals, Inc.

Timolol Maleate Eye Solution (FDC Limited) - Defective Container (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

FDAApr 18, 2025Nationwide• FDC Limited

Bard Intragastric Balloon Tube (C.R. Bard) – Plug Removal (2025)

Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.

Moderate

FDAApr 17, 2025AL, AK, AZ +49 more• C.R. Bard Inc

Bard Minnesota Tamponade Tube (C.R. Bard) – Plug Removal (2025)

Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.

Moderate

FDAApr 17, 2025AL, AK, AZ +49 more• C.R. Bard Inc

Straumann Healing Abutment (Straumann) – Blister Labeling (2025)

Incorrect blister labelling.

Moderate

FDAApr 17, 2025Nationwide• Straumann USA LLC

Tornado Embolization Microcoil (Cook) – Sizing Error (2025)

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.

Moderate

FDAApr 17, 2025Nationwide• Cook Incorporated

Bard Blakemore Tube (C.R. Bard) – Plug Removal Issue (2025)

Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.

Moderate

FDAApr 17, 2025AL, AK, AZ +49 more• C.R. Bard Inc