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Showing 4721–4740 of 14370 results

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Benazepril HCl Tablets (Amneal) – tablet contamination (2019)

Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle

Class IIILow

FDASep 24, 2019Nationwide• Amneal Pharmaceuticals, Inc.

Q-min Supplement (Basic Reset) – Regulatory Non-Compliance (2019)

Products do not conform to Dietary Supplement CGMP regulations.

Class IIModerate

FDASep 23, 2019PR• Basic Reset Inc.

GH-C Supplement (Basic Reset) – Regulatory Non-Compliance (2019)

Products do not conform to Dietary Supplement CGMP regulations.

Class IIModerate

FDASep 23, 2019PR• Basic Reset Inc.

Body Mass Reset (Basic Reset Inc.) – CGMP Non-Compliance (2019)

Products do not conform to Dietary Supplement CGMP regulations.

Class IIModerate

FDASep 23, 2019PR• Basic Reset Inc.

SlimUp Capsules (Basic Reset Inc.) – CGMP Non-Compliance (2019)

Products do not conform to Dietary Supplement CGMP regulations.

Class IIModerate

FDASep 23, 2019PR• Basic Reset Inc.

pH-FX Supplement (Basic Reset) – Regulatory Non-Compliance (2019)

Products do not conform to Dietary Supplement CGMP regulations.

Class IIModerate

FDASep 23, 2019PR• Basic Reset Inc.

AquaLyte Supplement (Basic Reset) – Regulatory Non-Compliance (2019)

Products do not conform to Dietary Supplement CGMP regulations.

Class IIModerate

FDASep 23, 2019PR• Basic Reset Inc.

Ranitidine Hydrochloride Capsules 300mg (Sandoz) – NDMA Impurity (2019)

CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).

Class IIModerate

FDASep 23, 2019Nationwide• Sandoz, Inc

Mello-Tonin Supplement (Basic Reset) – Regulatory Non-Compliance (2019)

Products do not conform to Dietary Supplement CGMP regulations.

Class IIModerate

FDASep 23, 2019PR• Basic Reset Inc.

Pioglitazone Tablets (Macleods) – potency problem (2019)

Superpotent

Class IIModerate

FDASep 23, 2019Nationwide• Macleods Pharma Usa Inc

Ranitidine Capsules (Sandoz) – NDMA detection (2019)

CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).

Class IIModerate

FDASep 23, 2019Nationwide• Sandoz, Inc

Prednisolone Oral Solution (Morton Grove) – impurity issue (2019)

Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14

Class IIModerate

FDASep 23, 2019Nationwide• Morton Grove Pharmaceuticals, Inc.

Ranitidine Hydrochloride Capsules 150mg (Sandoz) – NDMA Impurity (2019)

CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).

Class IIModerate

FDASep 23, 2019Nationwide• Sandoz, Inc

Dino Min Supplement (Basic Reset) – Regulatory Non-Compliance (2019)

Products do not conform to Dietary Supplement CGMP regulations.

Class IIModerate

FDASep 23, 2019PR• Basic Reset Inc.

Vibrant Energy Drink (Basic Reset Inc.) – CGMP Non-Compliance (2019)

Products do not conform to Dietary Supplement CGMP regulations.

Class IIModerate

FDASep 23, 2019PR• Basic Reset Inc.

Ionyte Supplement (Basic Reset) – Regulatory Non-Compliance (2019)

Products do not conform to Dietary Supplement CGMP regulations.

Class IIModerate

FDASep 23, 2019PR• Basic Reset Inc.

Beta Factor Supplement (Basic Reset) – Regulatory Non-Compliance (2019)

Products do not conform to Dietary Supplement CGMP regulations.

Class IIModerate

FDASep 23, 2019PR• Basic Reset Inc.

TRIM UP Dietary Supplement (Basic Reset Inc.) – CGMP Non-Compliance (2019)

Products do not conform to Dietary Supplement CGMP regulations.

Class IIModerate

FDASep 23, 2019PR• Basic Reset Inc.

Bee Gold Supplement (Basic Reset) – Regulatory Non-Compliance (2019)

Products do not conform to Dietary Supplement CGMP regulations.

Class IIModerate

FDASep 23, 2019PR• Basic Reset Inc.

Vibrant Energy Drink (Basic Reset) – Regulatory Non-Compliance (2019)

Products do not conform to Dietary Supplement CGMP regulations.

Class IIModerate

FDASep 23, 2019PR• Basic Reset Inc.

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