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Showing 1941–1960 of 29086 results

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Aussie Bites (Universal Bakery) – Gluten Content (2024)

Product is labeled as gluten free but consumer advocacy group testing revealed results above 20ppm for gluten.

Class IIModerate

FDAMay 17, 2024IL, WA• Best Express Foods, Inc.

Raisin Bread (Breadman) – Undeclared Ingredients (2024)

Undeclared Allergen

Undeclared milk allergen and undeclared Yellow No. 5

Class IIModerate

FDAMay 16, 2024CA, IN, OR• Breadbox Co.

Brioche Toast (Breadman) – Undeclared Color (2024)

Undeclared Allergen

Undeclared Yellow No. 5

Class IIModerate

FDAMay 16, 2024CA, IN, OR• Breadbox Co.

Jalapeno Cheese Bagels (Breadman) – Undeclared Milk (2024)

Undeclared Allergen

Undeclared milk allergen

Class IIModerate

FDAMay 16, 2024CA, IN, OR• Breadbox Co.

EYLEA Injection (Regeneron) – Syringe Breakage Risk (2024)

Lack of Assurance of Sterility: Complaints of syringe breakage

Class IIModerate

FDAMay 15, 2024Nationwide• Regeneron Pharmaceuticals Inc

Epinephrine-Lidocaine Injection (Imprimis) – Sterility Issue (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 14, 2024Nationwide• Imprimis NJOF, LLC

Dexamethasone-Moxifloxacin Suspension (Imprimis) – Sterility Issue (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 14, 2024Nationwide• Imprimis NJOF, LLC

Moxifloxacin Injection (Imprimis) – Sterility Issue (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 14, 2024Nationwide• Imprimis NJOF, LLC

Klarity-C Ophthalmic Emulsion (Imprimis) – Sterility Issue (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 14, 2024Nationwide• Imprimis NJOF, LLC

Dexamethasone-Moxifloxacin Injection (Imprimis) – Sterility Issue (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 14, 2024Nationwide• Imprimis NJOF, LLC

Prednisolone-Moxifloxacin Suspension (Imprimis) – Sterility Issue (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 14, 2024Nationwide• Imprimis NJOF, LLC

Moxifloxacin Injection (Imprimis) – Sterility Issue (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 14, 2024Nationwide• Imprimis NJOF, LLC

Nicardipine Injection (American Regent) – Sterility Concern (2024)

Lack of Assurance of Sterility.

Class IIModerate

FDAMay 14, 2024UT• American Regent, Inc.

Epinephrine-Lidocaine Injection (Imprimis) – Sterility Issue (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 14, 2024Nationwide• Imprimis NJOF, LLC

Rizatriptan Tablets (Glenmark) – Impurity Concern (2024)

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

Class IIModerate

FDAMay 13, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Vasopressin Injection (American Regent) – Subpotent Product (2024)

Subpotent product in addition to having out-of-specification results for impurities.

Class IIModerate

FDAMay 13, 2024Nationwide• American Regent, Inc.

Rizatriptan Benzoate Tablets (Glenmark) – Nitrosamine Impurity (2024)

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

Class IIModerate

FDAMay 13, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Duloxetine Capsules (Golden State) – Nitrosamine Contamination (2024)

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.

Class IIModerate

FDAMay 13, 2024Nationwide• Golden State Medical Supply Inc.

Price Chopper Cottage Cheese (HP Hood) – Undeclared Sugar (2024)

Undeclared Allergen

Contains undeclared sugar

Class IIModerate

FDAMay 10, 2024NY• HP Hood (LAFARGEVILLE)

Rizatriptan Benzoate Tablets (Glenmark) – Nitrosamine Impurity (2024)

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

Class IIModerate

FDAMay 10, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

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