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FentaNYL Citrate IV Bags (SterRx) – Sterility Issue (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 25, 2022Nationwide• SterRx, LLC

FentaNYL Citrate IV Bags (SterRx) – Sterility Concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 25, 2022Nationwide• SterRx, LLC

Aivia Whey Protein Chocolate (Nature's Sunshine) – undeclared milk (2022)

Label declares Whey but does not declare Milk.

Class IIModerate

FDAJul 22, 2022Nationwide• NATURE'S SUNSHINE PRODUCTS

Bob's Red Mill Organic Amaranth Grain (Bob's Red Mill) – Salmonella Risk (2022)

Salmonella

Potential to be contaminated with Salmonella.

Class IIModerate

FDAJul 22, 2022CA, CT, FL +14 more• Bob's Red Mill Natural Foods, Inc.

Aivia Whey Protein Vanilla Bean (Nature's Sunshine) – Undeclared Milk (2022)

Label declares Whey but does not declare Milk.

Class IIModerate

FDAJul 22, 2022Nationwide• NATURE'S SUNSHINE PRODUCTS

Matzim LA (Teva) – Dissolution Specification Failure (2022)

Failed Dissolution Specifications: below specification limits for dissolution.

Class IIModerate

FDAJul 21, 2022Nationwide• Teva Pharmaceuticals USA Inc

Matzim LA Tablets (Teva) – Dissolution Failure (2022)

Failed Dissolution Specifications: below specification limits for dissolution.

Class IIModerate

FDAJul 21, 2022Nationwide• Teva Pharmaceuticals USA Inc

Amaranth Grain Organic (Natural Grocers) – Salmonella Risk (2022)

Salmonella

Potential to be contaminated with Salmonella

Class IIModerate

FDAJul 21, 2022AZ, AR, CO +18 more• Vitamin Cottage Natural Food Markets, Inc.

Just Egg Spring Greens (Eat Just) – Listeria Contamination (2022)

Listeria

Listeria monocytogenes contamination.

Class IIModerate

FDAJul 20, 2022CA, GA, TX• EAT JUST INC

Organic Amaranth (Smirks Ltd) – Salmonella Risk (2022)

Salmonella

Potential to be contaminated with Salmonella.

Class IIModerate

FDAJul 20, 2022CA, CO, IL +3 more• Smirks Ltd

Sweetums Preservative Free Sucrose (Clinical Innovations) – Product Defect (2022)

Firm received complaints of leaking cups, black liquid, and black particulates in the 24% Sucrose Solution.

Class IIModerate

FDAJul 19, 2022Nationwide• Clinical Innovations, LLC

Sweetums Preservative Free Solution (Clinical Innovations) – Product Defect (2022)

Firm received complaints of leaking, black liquid, and black particulates in the product vials.

Class IIModerate

FDAJul 19, 2022Nationwide• Clinical Innovations, LLC

Prednisone Tablets (Strides Pharma) – Foreign Tablet Contamination (2022)

Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets

Class IIModerate

FDAJul 19, 2022Nationwide• Strides Pharma Inc.

Luxury Isopropyl Alcohol (Tsm Brands) – Undeclared Alcohol (2022)

Undeclared Allergen

Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol

Class IIModerate

FDAJul 19, 2022IN, VA• Tsm Brands LLC

Luxury Isopropyl Alcohol (Tsm Brands) – Undeclared Alcohol (2022)

Undeclared Allergen

Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol

Class IIModerate

FDAJul 19, 2022IN, VA• Tsm Brands LLC

Sweetums Sucrose Solution (Clinical Innovations) – Product Defect (2022)

Firm received complaints of leaking, black liquid, and black particulates in the product vials.

Class IIModerate

FDAJul 19, 2022Nationwide• Clinical Innovations, LLC

Creamy Parmesan Risotto (Ragozzino Foods) – Foreign Material (2022)

Product may contain foreign material, specifically glass.

Class IIModerate

FDAJul 19, 2022CA, FL, IL +1 more• Ragozzino Foods, Inc.

Fancy Buckwheat Flour (Minn Dak) – foreign material (2022)

Foreign Material - plastic

Class IIModerate

FDAJul 18, 2022IN• Minn Dak Growers, Ltd.

Sun-Dried Tomato Pesto (Bella Cucina) – undeclared milk (2022)

Label does not indicate milk on the label.

Class IIModerate

FDAJul 18, 2022AL, AK, AZ +42 more• Bella Brands, LLC DBA Bella Cucina Artful Food

Fresh Basil Pesto (Bella Cucina) – undeclared milk (2022)

Label does not indicate milk on the label.

Class IIModerate

FDAJul 18, 2022AL, AK, AZ +42 more• Bella Brands, LLC DBA Bella Cucina Artful Food

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