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Showing 801–820 of 29086 results

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Rapidol Arnica Tablets (Pharmadel) – cGMP Deviation (2025)

cGMP deviations

Class IIModerate

FDAApr 15, 2025DE• Pharmadel, LLC

DoloDent Toothache Drops (Pharmadel) – cGMP Deviation (2025)

cGMP deviations

Class IIModerate

FDAApr 15, 2025DE• Pharmadel, LLC

Rapidol Arnica Gel (Pharmadel) – cGMP Deviation (2025)

cGMP deviations

Class IIModerate

FDAApr 15, 2025DE• Pharmadel, LLC

Kingskin Wart Removal (Pharmadel) – cGMP Deviation (2025)

cGMP deviations

Class IIModerate

FDAApr 15, 2025DE• Pharmadel, LLC

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

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

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

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

Gluten Free Vanilla Cake (Emily Kate's) – foil fragment (2025)

Foreign material (foil) found in cake slices

Class IIModerate

FDAApr 11, 2025IN, WI• Emily Kate's Foods

Gluten Free Carrot Cake (Emily Kate's) – foil fragment (2025)

Foreign material (foil) found in cake slices

Class IIModerate

FDAApr 11, 2025IN, WI• Emily Kate's Foods

Testosterone Cypionate Injection (Eugia US LLC) – Crystal Dissolution Issue (2025)

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

Class IIModerate

FDAApr 10, 2025Nationwide• Eugia US LLC

ClomiPRAMINE Hydrochloride Capsules (Lupin) – Impurity Specification Failure (2025)

Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.

Class IIModerate

FDAApr 10, 2025Nationwide• Lupin Pharmaceuticals Inc.

Levothyroxine Sodium Tablets (Accord Healthcare) – Subpotent Medication (2025)

Subpotent

Class IIModerate

FDAApr 10, 2025Nationwide• ACCORD HEALTHCARE, INC.

Levothyroxine 50mcg (ACCORD) – Subpotent (2025)

Subpotent

Class IIModerate

FDAApr 10, 2025Nationwide• ACCORD HEALTHCARE, INC.

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