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Showing 2581–2600 of 68218 results

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Alinity m Resp-4-Plex Kit (Abbott) – Test Result Anomalies (2025)

There were reports of an increase in reactive negative controls and false positive results.

FDAApr 28, 2025Nationwide• Abbott Molecular, Inc.

Testosterone Pellet 200 mg (BSO LLC) – Glass Particle Contamination (2025)

Presence of Particulate Matter: Glass particles were found in pellet vials.

Class IIModerate

FDAApr 28, 2025Nationwide• BSO LLC

Testosterone Pellet 100mg (BSO) – Particulate Matter Risk (2025)

Presence of Particulate Matter: Glass particles were found in pellet vials.

Class IIModerate

FDAApr 28, 2025Nationwide• BSO LLC

Testosterone Pellet 200mg (BSO) – Particulate Matter Risk (2025)

Presence of Particulate Matter: Glass particles were found in pellet vials.

Class IIModerate

FDAApr 28, 2025Nationwide• BSO LLC

Testosterone Pellet 200 mg (BSO LLC) – Glass Particle Contamination (2025)

Presence of Particulate Matter: Glass particles were found in pellet vials.

Class IIModerate

FDAApr 28, 2025Nationwide• BSO LLC

Constellation Vision System (Alcon) – Manufacturing Damage (2025)

Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.

FDAApr 28, 2025Nationwide• Alcon Research LLC

Temper Tamer Oral Spray (Siddha Flower Essences) – Manufacturing Deviation (2025)

CGMP Deviations

Class IIModerate

FDAApr 28, 2025Nationwide• Siddha Flower Essences, LLC.

NxStage PureFlow-B Solution (NxStage) – Seal Failure Risk (2025)

Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior to treatment.

FDAApr 28, 2025Nationwide• NxStage Medical Inc

Testosterone Pellet 200 mg (BSO LLC) – Glass Particle Contamination (2025)

Presence of Particulate Matter: Glass particles were found in pellet vials.

Class IIModerate

FDAApr 28, 2025Nationwide• BSO LLC

Trader Joe's Sesame Miso Salmon Salad – undeclared milk (2025)

Undeclared Milk

undeclared milk

FDAApr 26, 2025AL, IL, IN +15 more• Taylor Farms Illinois Inc.

AcoSound Hearing Aid (AcoSound) – Labeling Error (2025)

Three issues 1. Label error: The manufacturer information in the labeling is not correct, the manufacturer's name is mislabeled as "Developed by AcoSound," Correct should be "Manufactured by Hangzhou AcoSound." And the labeling has no statement of the place of business for the manufacturer. 2. Customer information: The customer "Blaid" information is not correctly marked; Blaid is not the manufacturer. 3. UDI Information: The UDI information is incomplete and without DI information and correct Pl information, not complied with UDI label requirements.

FDAApr 25, 2025Nationwide• HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. No.2 Building Room 401 No.

15 Degree Stab Knife (Tecfen) – Sterility Assurance (2025)

Sterility assurance for Ophthalmic knives.

FDAApr 25, 2025Nationwide• Tecfen Medical

Mauna Loa Dark Chocolate Macadamias (Hawaiian Host) – Undeclared Nuts (2025)

Undeclared Allergen

Undeclared almond and cashew.

FDAApr 25, 2025AZ, CA, CO +14 more• HAWAIIAN HOST CANDIES OF LA INC

Vanilla Frozen Yogurt (Wells Enterprises) – Plastic Contamination (2025)

Foreign material (plastic) may be present in ice cream product

Class IIModerate

FDAApr 25, 2025Nationwide• Wells Enterprises, Inc.

GFGB Vanilla Bean Ice Cream – plastic contamination (2025)

Foreign material (plastic) may be present in ice cream product

Class IIModerate

FDAApr 25, 2025Nationwide• Wells Enterprises, Inc.

Vanilla Ice Cream (Wells Enterprises) – Plastic Contamination (2025)

Foreign material (plastic) may be present in ice cream product

Class IIModerate

FDAApr 25, 2025Nationwide• Wells Enterprises, Inc.

Quick Blend Vanilla Ice Cream (Wells) – Plastic Contamination (2025)

Foreign material (plastic) may be present in ice cream product

Class IIModerate

FDAApr 25, 2025Nationwide• Wells Enterprises, Inc.

Glenview Farms Vanilla Ice Cream – plastic contamination (2025)

Foreign material (plastic) may be present in ice cream product

Class IIModerate

FDAApr 25, 2025Nationwide• Wells Enterprises, Inc.

Glenview Farms French Vanilla Ice Cream (Wells) – Plastic Contamination (2025)

Foreign material (plastic) may be present in ice cream product

Class IIModerate

FDAApr 25, 2025Nationwide• Wells Enterprises, Inc.

GFGB 12% Vanilla Ice Cream – plastic contamination (2025)

Foreign material (plastic) may be present in ice cream product

Class IIModerate

FDAApr 25, 2025Nationwide• Wells Enterprises, Inc.

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