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Showing 4501–4520 of 29086 results

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Dental Health Supplement (Eden's Answers) – Bacterial Growth (2022)

High bacterial growth within products

Class IIModerate

FDASep 22, 2022AL, AK, AZ +34 more• Eden's Answers Inc

Lil Ones Sleepy Time (Eden's Answers) – Bacterial Growth (2022)

High bacterial growth within products

Class IIModerate

FDASep 22, 2022AL, AK, AZ +34 more• Eden's Answers Inc

Italian Dressing (Treehouse Foods) – Undeclared Allergens (2022)

Undeclared Soy

Undeclared soy and wheat.

Class IIModerate

FDASep 22, 2022AL, CA, CT +17 more• Treehouse Foods

Honey Herbal Syrup (Eden's Answers) – Bacterial Growth (2022)

High bacterial growth within products

Class IIModerate

FDASep 22, 2022AL, AK, AZ +34 more• Eden's Answers Inc

Ampicillin Injection (Viatris) – particulate contamination (2022)

Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.

Class IIModerate

FDASep 21, 2022Nationwide• Viatris Inc

Rifampin Capsules 150mg (Akorn) – impurity specification (2022)

Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).

Class IIModerate

FDASep 21, 2022Nationwide• Akorn, Inc.

Rifampin Capsules (Akorn) – Impurity Specification Failure (2022)

Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).

Class IIModerate

FDASep 21, 2022Nationwide• Akorn, Inc.

Indian Gooseberry Extract (Secrets of the Tribe) – High Lead (2022)

Product has elevated level of lead.

Class IIModerate

FDASep 19, 2022Nationwide• Secrets Of The Tribe

Amla Alcohol-Free Extract (Secrets of the Tribe) – High Lead (2022)

Product has elevated level of lead.

Class IIModerate

FDASep 19, 2022Nationwide• Secrets Of The Tribe

Peach Cottage Cheese (Turner's) – Bacterial Spoilage (2022)

Bacterial spoilage in cottage cheese

Class IIModerate

FDASep 16, 2022IN, PA• Titusville Dairy Products Co.

Apple Cinnamon Cottage Cheese (Turner's) – Bacterial Spoilage (2022)

Bacterial spoilage in cottage cheese

Class IIModerate

FDASep 16, 2022IN, PA• Titusville Dairy Products Co.

Yellowfin Tuna Poke (Tidal Seafood) – High Histamine (2022)

Frozen Tuna may contain elevated levels of Histamine

Class IIModerate

FDASep 16, 2022CA, IN, NM +1 more• WORLDWIDE SEAFOOD PRODUCTS LLC

Neoral Cyclosporine Capsules (Novartis) – Ethanol Content Issue (2022)

CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.

Class IIModerate

FDASep 16, 2022Nationwide• Novartis Pharmaceuticals Corporation

Multivitamin Chewables (Seeking Health) – Copper Levels (2022)

The product label claim for copper is 0.5mg, but third-party lab results revealed product contains higher levels of copper.

Class IIModerate

FDASep 16, 2022AL, AK, AZ +48 more• Seeking Health LLC

Pineapple Cottage Cheese (Turner's) – Bacterial Spoilage (2022)

Bacterial spoilage in cottage cheese

Class IIModerate

FDASep 16, 2022IN, PA• Titusville Dairy Products Co.

Whole Milk Cottage Cheese (Turner's) – Bacterial Spoilage (2022)

Bacterial spoilage in cottage cheese

Class IIModerate

FDASep 16, 2022IN, PA• Titusville Dairy Products Co.

Yellowfin Tuna Saku Block (Tidal Seafood) – High Histamine (2022)

Frozen Tuna may contain elevated levels of Histamine

Class IIModerate

FDASep 16, 2022CA, IN, NM +1 more• WORLDWIDE SEAFOOD PRODUCTS LLC

Tuna Round Steaks (Tidal Seafood) – High Histamine (2022)

Frozen Tuna may contain elevated levels of Histamine

Class IIModerate

FDASep 16, 2022CA, IN, NM +1 more• WORLDWIDE SEAFOOD PRODUCTS LLC

Budesonide Inhalation Suspension (CIPLA) – Sterility Concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDASep 15, 2022Nationwide• CIPLA

Cheese Straws (Flathau's) – Undeclared Allergens (2022)

Undeclared Allergen

Undeclared Allergens - Wheat & Milk

Class IIModerate

FDASep 15, 2022AL, AR, IN +10 more• Flathau's Fine Foods

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