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

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.

Class IIModerate

FDAApr 24, 2019Nationwide• AVKARE Inc.

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

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.

Class IIModerate

FDAApr 24, 2019Nationwide

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

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

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

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

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

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

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

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

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

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

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

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

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

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

EZY Gel Topical Anesthetic (Biotouch) – safety closure (2019)

Losartan Potassium Tablets (Camber) – Impurity Detection (2019)

Losartan Hydrochlorothiazide Tablets (Torrent) – Impurity Risk (2019)

Losartan Potassium Tablets (Camber) – Impurity Detection (2019)

Losartan Potassium Tablets (Camber) – Impurity Detection (2019)

Numb 100 Topical Anesthetic (Clinical Resolution) – safety closure (2019)