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Showing 2481–2500 of 29086 results

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Salami & Cheese Bagel (Gaws) - Undeclared Sesame (2023)

Undeclared Allergen

undeclared sesame

Class IIModerate

FDANov 29, 2023MI• Gaws Gourmet Foods

Classic Italian Sub (Gaws Gourmet) – Undeclared Sesame (2023)

Undeclared Allergen

undeclared sesame

Class IIModerate

FDANov 29, 2023MI• Gaws Gourmet Foods

Deluxe Italian Sub (Gaws Gourmet) – Undeclared Sesame (2023)

Undeclared Allergen

undeclared sesame

Class IIModerate

FDANov 29, 2023MI• Gaws Gourmet Foods

XL Ham & Cheese Sub (Gaws) - Undeclared Sesame (2023)

Undeclared Allergen

undeclared sesame

Class IIModerate

FDANov 29, 2023MI• Gaws Gourmet Foods

Hawaiian Volcanic Water (Waiakea) – Floating Particles (2023)

Consumer complaints involving floating particles.

Class IIModerate

FDANov 28, 2023CO, FL, GA +6 more• Waiakea Bottling Inc

Penicillamine Tablets (Lupin) – Dissolution Failure (2023)

Failed Dissolution Specifications

Class IIModerate

FDANov 22, 2023Nationwide• Lupin Pharmaceuticals Inc.

Thiamine/Pyridoxine Injection (AnazaoHealth) – Particulate Matter (2023)

Presence of Particulate Matter.

Class IIModerate

FDANov 22, 2023Nationwide• AnazaoHealth Corporation

ceFAZolin Sodium Injection (Wells Pharma) – Sterility Concern (2023)

Lack of assurance of sterility.

Class IIModerate

FDANov 22, 2023PA• Wells Pharma of Houston LLC

B-Complex Injection (AnazaoHealth) – Particulate Matter (2023)

Presence of Particulate Matter.

Class IIModerate

FDANov 22, 2023Nationwide• AnazaoHealth Corporation

Vegan Pumpkin Pie (Willamette Valley Pie) – Foreign Object (2023)

Foreign object

Class IIModerate

FDANov 21, 2023CA, IL, IN +9 more• Willamette Valley Pie Company, LLC

M.T.go Double Dipped Chocolatey (Sheetz) – Undeclared Soy (2023)

Product contains undeclared soy.

Class IIModerate

FDANov 20, 2023NC, VA, WV• Sheetz Distribution Services, LLC

Sienna Bakery Chocolate Decadent Brownies (Dianne's Fine Desserts) – Undeclared Peanuts (2023)

Undeclared Nuts

Contains undeclared peanuts.

Class IIModerate

FDANov 18, 2023AR, FL, IL +11 more• Dianne's Fine Desserts

Vermont Village Apple Sauce (Stonewall Kitchen) – Patulin Levels (2023)

Product contains elevated levels of patulin

Class IIModerate

FDANov 17, 2023AR, CA, CT +21 more• Stonewall Kitchen, LLC

Egg Custard Pie (Publix) - Undeclared Tree Nut (2023)

Undeclared Nuts

Undeclared Tree Nut (Coconut)

Class IIModerate

FDANov 16, 2023FL• Publix Super Markets, Inc.

Ondansetron Injection (Baxter) – Failed pH Specs (2023)

Failed pH Specifications

Class IIModerate

FDANov 14, 2023Nationwide• Baxter Healthcare Corporation

KinderMed Kids' Acetaminophen (Kinder Farms) – Impurity Specs (2023)

Failed Impurities/Degradation Specifications

Class IIModerate

FDANov 13, 2023Nationwide• KINDER FARMS LLC

KinderMed Infants' Pain Acetaminophen (Kinder Farms) – impurity issue (2023)

Failed Impurities/Degradation Specifications

Class IIModerate

FDANov 13, 2023Nationwide• KINDER FARMS LLC

Paroxetine 10mg Tablets (Golden State Medical) – impurity specification (2023)

Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine

Class IIModerate

FDANov 10, 2023Nationwide• Golden State Medical Supply Inc.

Paroxetine 20mg Tablets (Golden State Medical) – impurity specification (2023)

Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine

Class IIModerate

FDANov 10, 2023Nationwide• Golden State Medical Supply Inc.

Paroxetine 40mg Tablets (Golden State Medical) – impurity specification (2023)

Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine

Class IIModerate

FDANov 10, 2023Nationwide• Golden State Medical Supply Inc.

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