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Losartan Potassium 50mg Tablets (Teva) – NMBA Impurity (2019)

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Class IIModerate

FDAJun 6, 2019Nationwide• Teva Pharmaceuticals USA

Losartan Potassium 100mg Tablets (Teva) – NMBA Impurity (2019)

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Class IIModerate

FDAJun 6, 2019Nationwide

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Losartan Potassium 50mg Tablets (Teva) – NMBA Impurity (2019)

Losartan Potassium 100mg Tablets (Teva) – NMBA Impurity (2019)

Great Value Blackberries (Riverside Foods) – norovirus contamination (2019)

Tipton Grove Frozen Mixed Berries (Riverside Foods) – norovirus contamination (2019)

Acid Rain Fat Destroyer (Nexagen) – ingredient mislabeling (2019)

Losartan Potassium Tablets (AVKARE) – NMBA Impurity (2019)

Losartan Potassium Tablets (AVKARE) – NMBA Impurity (2019)

Losartan Potassium Tablets (Legacy) – NMBA Impurity (2019)

Losartan Potassium Tablet (Torrent Pharma) – Impurity Detection (2019)

Losartan Potassium Tablet (Torrent Pharma) – Impurity Detection (2019)

Losartan/Hydrochlorothiazide Tablet (Torrent Pharma) – Impurity Detection (2019)

Losartan Hydrochlorothiazide Tablets (Torrent Pharma) – NMBA Impurity (2019)

Losartan Potassium Tablet (Torrent Pharma) – Impurity Detection (2019)

Losartan Potassium Tablets (Torrent Pharma) – NMBA Impurity (2019)

Valsartan 40mg Tablets (Rising) – CGMP Impurity (2019)

Valsartan 160mg Tablets (Rising) – CGMP Impurity (2019)

Valsartan 80mg Tablets (Rising) – CGMP Impurity (2019)

Valsartan 320mg Tablets (Rising) – CGMP Impurity (2019)

Losartan Potassium Tablets (Legacy) – Impurity Risk (2019)

Losartan Potassium Tablets (Legacy) – Impurity Risk (2019)