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Showing 2741–2760 of 68218 results

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VITROS Chemistry CRP Slides (Ortho-Clinical) – Labeling Error (2025)

Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.

FDAApr 14, 2025Nationwide• Ortho-Clinical Diagnostics, Inc.

Augmedics Perc Pin Adaptor (Augmedics) – Tightening Marking (2025)

The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.

FDAApr 14, 2025Nationwide• Augmedics Ltd. 2 Ha-Otsma St Yokneam Illit Northern Israel

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Class IIModerate

FDAApr 14, 2025Nationwide• Breckenridge Pharmaceutical, Inc

Ultra Armor (SAINI TRADE) – Undeclared Ingredients (2025)

Undeclared Allergen

Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.

FDAApr 14, 2025Nationwide• SAINI TRADE INC

Male Ultra (SAINI TRADE) – Undeclared Ingredients (2025)

Undeclared Allergen

Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.

FDAApr 14, 2025Nationwide• SAINI TRADE INC

Electro Buzz (SAINI TRADE) – Undeclared Ingredients (2025)

Undeclared Allergen

Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.

FDAApr 14, 2025Nationwide• SAINI TRADE INC

Male Ultra Pro (SAINI TRADE) – Undeclared Ingredients (2025)

Undeclared Allergen

Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.

FDAApr 14, 2025Nationwide• SAINI TRADE INC

Malextra Supplement (SAINI TRADE) – Undeclared Ingredients (2025)

Undeclared Allergen

Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.

FDAApr 14, 2025Nationwide• SAINI TRADE INC

ChlorproMAZINE Tablets (Harvard Drug) – Nitrosamine Impurity (2025)

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

Class IIModerate

FDAApr 14, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Class IIModerate

FDAApr 14, 2025Nationwide• Breckenridge Pharmaceutical, Inc

Glidewell HT Implant Drill (Prismatik) – Packaging Mixup (2025)

Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.

FDAApr 14, 2025Nationwide• Prismatik Dentalcraft, Inc.

Cilantro Salsa (MegaMex Foods) – foreign wood pieces (2025)

Firm's salsa product was potentially manufactured with a recalled ingredient (Fresh Cilantro containing foreign objects "wood pieces")

Class IIModerate

FDAApr 14, 2025CA, IN, MI +3 more• MegaMex Foods LLC

Microtek Patient Drape (Microtek) – Sterility Concern (2025)

Due to non-sterile products being labeled as sterile

FDAApr 13, 2025AL, AR, CA +17 more• Microtek Medical, Inc.

Hulled Sunflower Kernels (JJ Nuts) – glass fragments (2025)

Glass fragments found in finished product.

Class IIModerate

FDAApr 13, 2025MD, PA• JJ Nuts, LLC

Multigrain Sourdough (Upper Crust) – glass fragment (2025)

Glass fragment found on top of bread.

Class IIModerate

FDAApr 12, 2025CA, CT, DE +3 more• Upper Crust Bakery LP

Multigrain Sourdough (Giant Eagle) – glass risk (2025)

Firm is recalling product due to the potential of foreign material (glass)

Class IIModerate

FDAApr 12, 2025IN, MD, OH +2 more• Giant Eagle, Inc.

Ancient Grains Hoagie Roll (Upper Crust) – glass fragment (2025)

Glass fragment found on top of bread.

Class IIModerate

FDAApr 12, 2025CA, CT, DE +3 more• Upper Crust Bakery LP

Whole Grain Multigrain (Upper Crust) – glass fragment (2025)

Glass fragment found on top of bread.

Class IIModerate

FDAApr 12, 2025CA, CT, DE +3 more• Upper Crust Bakery LP

Cookie Butter Banana Pie (Dianne's) – undeclared almonds (2025)

Undeclared Allergen

Contains undeclared allergens (almonds).

Class IIModerate

FDAApr 12, 2025CA, FL, IL +13 more• Dianne's Fine Desserts

Centerline IOPS Guidewire (Centerline) – Coating Failure (2025)

Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.

FDAApr 11, 2025FL, NM, NY +5 more• Centerline Biomedical Inc

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