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Showing 3161–3180 of 29086 results

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Losartan Tablets (Strides) – Foreign Substance (2023)

Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.

Class IIModerate

FDAJun 26, 2023Nationwide• Strides Pharma Inc.

Cream Cheese Rangoon (Pegasus Foods) – Foreign Object (2023)

Plastic foreign object found in product.

Class IIModerate

FDAJun 26, 2023CA• Pegasus Foods, Inc.

Trisodium Citrate Dihydrate (Cargill) – Metal contamination (2023)

Potential for foreign material (metal).

Class IIModerate

FDAJun 23, 2023AZ, CA, DE +11 more• Cargill, Inc Corporate Headquarters

Tizanidine 4mg Tablets (Amerisource) – Dissolution Specifications (2023)

Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.

Class IIModerate

FDAJun 23, 2023Nationwide• Amerisource Health Services LLC

Safe Tussin DM Cough Syrup (Kramer) – Non-Food Grade Lubricant (2023)

CGMP Deviations: use of non-food grade lubricant in mixing vessel.

Class IIModerate

FDAJun 23, 2023Nationwide• Kramer Laboratories, Inc.

Safe Tussin PM Cough Syrup (Kramer) – Non-Food Grade Lubricant (2023)

CGMP Deviations: use of non-food grade lubricant in mixing vessel.

Class IIModerate

FDAJun 23, 2023Nationwide• Kramer Laboratories, Inc.

Apple Cider (CN Smith) – Patulin Contamination (2023)

Product contains high levels of patulin (above 50ppb).

Class IIModerate

FDAJun 23, 2023CT, MA, NH +1 more• Bevovations, LLC

Tripotassium Citrate (Cargill) – Metal Contamination (2023)

Potential for foreign material (metal).

Class IIModerate

FDAJun 23, 2023AZ, CA, DE +11 more• Cargill, Inc Corporate Headquarters

Diclofenac Sodium Topical Solution (Alembic) – Delivery System Defect (2023)

Defective Delivery System

Class IIModerate

FDAJun 22, 2023Nationwide• ALEMBIC PHARMACEUTICALS, INC.

Zinc Sulfate Monohydrate (Jost Chemical) – Lead contamination (2023)

Zinc Sulfate Monohydrate, USP may contain elevated levels of lead.

Class IIModerate

FDAJun 22, 2023Nationwide• Jost Chemical Co

Level-1 Protein (1st Phorm) – Bacterial contamination (2023)

Product may contain Staphylococcus aureus.

Class IIModerate

FDAJun 21, 2023MO• International Food Companies DBA International Food Products

Tizanidine 4mg Tablets (Dr Reddy's) – Dissolution Specification (2023)

Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.

Class IIModerate

FDAJun 21, 2023Nationwide• Dr Reddy's Laboratories Limited

Tampico Mango Punch (Garelick Farms) – Undeclared color (2023)

Undeclared Allergen

Product contains undeclared Yellow 5.

Class IIModerate

FDAJun 21, 2023CT, MA, NH +3 more• Garelick Farms LLC

Romaine Lettuce (G.O. Corporation) – Deer Feces Contamination (2023)

Romaine lettuce may be contaminated with deer feces.

Class IIModerate

FDAJun 16, 2023IA, MN, ND +1 more• G.O. Corporation

Lett Blend Rom/End/Rad (G.O. Corporation) – Deer Feces Contamination (2023)

Romaine lettuce may be contaminated with deer feces.

Class IIModerate

FDAJun 16, 2023IA, MN, ND +1 more• G.O. Corporation

Tramadol Hydrochloride Tablets (Harvard Drug) – Packaging Defect (2023)

Packaging defect: blister packaging inadequately sealed.

Class IIModerate

FDAJun 16, 2023Nationwide• The Harvard Drug Group

Romaine Lettuce (C&E Farms) – Deer Droppings Contamination (2023)

Product possibly contaminated with deer droppings

Class IIModerate

FDAJun 16, 2023MA, MN• C&E Farms, Inc.

Lettuce Salad Blend Monterey (G.O. Corporation) – Deer Feces Contamination (2023)

Romaine lettuce may be contaminated with deer feces.

Class IIModerate

FDAJun 16, 2023IA, MN, ND +1 more• G.O. Corporation

Snack Tray (Wegmans) – Undeclared Allergens (2023)

Undeclared Gluten

Undeclared almonds and/or undeclared wheat

Class IIModerate

FDAJun 15, 2023IN, NY, PA• Stellex/CF Houston, LLC

Snack Tray (Wegmans) – Undeclared Allergens (2023)

Undeclared Gluten

Undeclared almonds and/or undeclared wheat

Class IIModerate

FDAJun 15, 2023IN, NY, PA• Stellex/CF Houston, LLC

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