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Black Label X Capsules (Making It a Lifestyle) – undeclared sildenafil (2016)

Undeclared Allergen

Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.

Class IHigh

FDAApr 29, 2016Nationwide• Making It a Lifestyle

Cookie Tray (Giant Eagle) – Undeclared Milk (2016)

Giant Eagle discovered that the ingredient statement for Pecan Tassies fails to declare the milk ingredient. The allergen statement does not declare the milk allergen.

Class IHigh

FDAApr 28, 2016IN, MD, OH +2 more• Giant Eagle, Inc.

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Black Label X Capsules (Making It a Lifestyle) – undeclared sildenafil (2016)

Cookie Tray (Giant Eagle) – Undeclared Milk (2016)

Long Chili Peppers (Patel Shippers) – Salmonella Risk (2016)

Walnut Delights (Giant Eagle) – Undeclared Milk (2016)

Pecan Tassie (Giant Eagle) – Undeclared Milk (2016)

Xtreme Fiber Detox (World's Choice) – Undeclared Proteins (2016)

Supreme Elixir (World's Choice) – Undeclared Proteins (2016)

Nature's Blend Juice (World's Choice) – Undeclared Proteins (2016)

Chocolate Chunk Cookie (7-Eleven) – Undeclared Peanuts (2016)

7-Eleven Oatmeal Raisin Cookie (Glenn Wayne) – Undeclared Peanuts (2016)

7-Eleven Sugar M&M Cookie (Glenn Wayne) – Undeclared Peanuts (2016)

Bream Dry Salted Fish (Krasnyi Oktyabr) – Uneviscerated Product (2016)

Vobla Dry Salted Fish (Krasnyi Oktyabr) – Uneviscerated Product (2016)

Ivory Teff Flour (Bridgewell) – Salmonella Risk (2016)

7-Eleven Oatmeal Raisin Cookie (Bakery Express) – Undeclared Peanuts (2016)

7-Eleven Fresh to Go Chocolate Chunk Cookie (Bakery Express) – Undeclared peanuts (2016)

Organic Sweet Baby Peas (CRF Frozen Foods) – Listeria risk (2016)

Organic Vegetable Medley (CRF Frozen Foods) – Listeria risk (2016)

Wellsley Farms Organic Mixed Vegetables (CRF Frozen Foods) – Listeria risk (2016)

Organic White Sweet Corn (CRF Frozen Foods) – Listeria risk (2016)