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Showing 1861–1880 of 2326 results

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Metformin Hydrochloride Extended-Release (Denton Pharma) - NDMA Impurity (2020)

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

Class IIModerate

FDAOct 8, 2020Nationwide• Denton Pharma, Inc.

Metformin Hydrochloride Extended-Release (Denton Pharma) - NDMA Impurity (2020)

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

Class IIModerate

FDAOct 8, 2020Nationwide• Denton Pharma, Inc.

Killz Germz Hand Sanitizer (Genesis Partnership) – Sub-Potent Ethanol (2020)

Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.

Class IIModerate

FDASep 11, 2020Nationwide• Genesis Partnership Company SA

Genesis Hand Sanitizer Gel (Genesis Partnership) – Manufacturing Deviation (2020)

CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.

Class IIModerate

FDASep 11, 2020Nationwide• Genesis Partnership Company SA

Panagel Hand Sanitizer (Genesis Partnership) – Manufacturing Deviation (2020)

CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.

Class IIModerate

FDASep 11, 2020Nationwide• Genesis Partnership Company SA

Killz Germz Hand Sanitizer (Genesis Partnership) – Sub-Potent Alcohol (2020)

Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.

Class IIModerate

FDASep 11, 2020Nationwide• Genesis Partnership Company SA

Genesis Hand Sanitizer Gel (Genesis Partnership) – Manufacturing Deviation (2020)

CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.

Class IIModerate

FDASep 11, 2020Nationwide• Genesis Partnership Company SA

Elitek Injection (Sanofi-Aventis) - Stability Failure (2020)

Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.

Class IIModerate

FDAAug 10, 2020Nationwide• Sanofi-Aventis U.S. LLC

Wegmans Valencia Oranges (Freshouse Produce) – Listeria risk (2020)

The firm received positive Environmental sampling results for Listeria monocytogenes.

Class IIModerate

FDAAug 7, 2020IN, MD, NC +3 more• Freshouse Produce

Limes (Freshouse) – Listeria Contamination (2020)

The firm received positive Environmental sampling results for Listeria monocytogenes.

Class IIModerate

FDAAug 7, 2020IN, MD, NC +3 more• Freshouse Produce

Lemons (Freshouse) – Listeria Contamination (2020)

The firm received positive Environmental sampling results for Listeria monocytogenes.

Class IIModerate

FDAAug 7, 2020IN, MD, NC +3 more• Freshouse Produce

Assured Vitamin E Hand Sanitizer (Albek De Mexico) – ethanol contamination (2020)

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Class IIModerate

FDAJul 30, 2020Nationwide• Albek De Mexico S.A. De C.V.

O-Snap! Chocolate Bar (Sweeteeth) – Undeclared soy (2020)

The firm was notified by the South Carolina Dept. of Agriculture that the product contains soy which is not included on the label.

Class IIModerate

FDAJul 30, 2020GA, SC• Sweeteeth Chocolate LLC

NuuxSan Hand Sanitizer (Albek De Mexico) – ethanol contamination (2020)

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Class IIModerate

FDAJul 30, 2020Nationwide• Albek De Mexico S.A. De C.V.

Next Advanced Hand Sanitizer (Albek De Mexico) – ethanol contamination (2020)

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Class IIModerate

FDAJul 30, 2020Nationwide• Albek De Mexico S.A. De C.V.

Modesa Hand Sanitizer (Albek De Mexico) – ethanol contamination (2020)

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Class IIModerate

FDAJul 30, 2020Nationwide• Albek De Mexico S.A. De C.V.

Assured Hand Sanitizer (Albek De Mexico) – ethanol contamination (2020)

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Class IIModerate

FDAJul 30, 2020Nationwide• Albek De Mexico S.A. De C.V.

Metformin Hydrochloride Extended-Release 750mg (Granules) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAJul 3, 2020Nationwide• Granules Pharmaceuticals Inc

Metformin Hydrochloride Extended-Release (Amneal) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAMay 29, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC

Metformin Hydrochloride Extended-Release Tablets (Amneal) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAMay 29, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC

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