Undeclared Wheat. The firm was notified by a consumer that they found crispy onions in the packaging of the tortilla strips. The onions contain wheat which is not listed on the packaging for the tortilla strips.

Class IIModerate

FDANov 21, 2024AZ, CA, CO +19 more• SUGAR FOODS LLC

Ricotta Stuffed Shells (Hungryroot) – Listeria Risk (2024)

Listeria

Products have the potential to be contaminated with Listeria monocytogenes.

Class IIModerate

FDANov 20, 2024AZ, CA, DE +3 more• Joseph Epstein Food Enterprises, Inc. dba MamaMancini's

Chipotle Con Queso (Jose Madrid) – Undeclared Dye (2024)

Undeclared Allergen

Undeclared Yellow #5 and Yellow #6

Class IIModerate

FDANov 20, 2024AL, CO, FL +14 more• Michael Zakany LLC

Stuffed Shells (Mama Mancini's) – Listeria Risk (2024)

Listeria

Products have the potential to be contaminated with Listeria monocytogenes.

Class IIModerate

FDANov 20, 2024AZ, CA, DE +3 more• Joseph Epstein Food Enterprises, Inc. dba MamaMancini's

Levothyroxine Sodium 125mcg Tablets (Mylan) – Potency Variation (2024)

Subpotent and Superpotent Drug

Class IIModerate

FDANov 19, 2024Nationwide• Mylan Institutional, Inc.

Duloxetine DR Capsules 60mg (Rising Pharma) – N-nitroso Impurity (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

Class IIModerate

FDANov 19, 2024Nationwide• Rising Pharma Holding, Inc.

Levothyroxine Sodium 100mcg Tablets (Mylan) – Potency Variation (2024)

Subpotent and Superpotent Drug

Class IIModerate

FDANov 19, 2024Nationwide• Mylan Institutional, Inc.

Levothyroxine Sodium 150mcg Tablets (Mylan) – Potency Variation (2024)

Subpotent and Superpotent Drug

Class IIModerate

FDANov 19, 2024Nationwide• Mylan Institutional, Inc.

Duloxetine DR Capsules 20mg (Rising Pharma) – N-nitroso Impurity (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

Class IIModerate

FDANov 19, 2024Nationwide• Rising Pharma Holding, Inc.

Levothyroxine Sodium 112mcg Tablets (Mylan) – Potency Variation (2024)

Subpotent and Superpotent Drug

Class IIModerate

FDANov 19, 2024Nationwide• Mylan Institutional, Inc.

Levothyroxine Sodium 137mcg Tablets (Mylan) – Potency Variation (2024)

Subpotent and Superpotent Drug

Class IIModerate

FDANov 19, 2024Nationwide• Mylan Institutional, Inc.

Levothyroxine Sodium 175mcg Tablets (Mylan) – Potency Variation (2024)

Subpotent and Superpotent Drug

Class IIModerate

FDANov 19, 2024Nationwide• Mylan Institutional, Inc.

Duloxetine DR Capsules 30mg (Rising Pharma) – N-nitroso Impurity (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

Class IIModerate

FDANov 19, 2024Nationwide• Rising Pharma Holding, Inc.

Levothyroxine Sodium 200mcg Tablets (Viatris) – Potency Variation (2024)

Superpotent Drug and Subpotent Drug: potency failures obtained

Class IIModerate

FDANov 18, 2024Nationwide• Viatris Inc

Levothyroxine Sodium 100mcg Tablets (Viatris) – Potency Variation (2024)

Superpotent Drug and Subpotent Drug: potency failures obtained

Class IIModerate

FDANov 18, 2024Nationwide• Viatris Inc

Levothyroxine Sodium Tablets 88 mcg (Viatris) – Potency Failures (2024)

Superpotent Drug and Subpotent Drug: potency failures obtained

Class IIModerate

FDANov 18, 2024Nationwide• Viatris Inc

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