Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
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Class II · Moderate risk
Ranitidine Tablets 75 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Dr. Reddy's: Ranitidine Capsules 150 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Rite Aid Pharmacy Maximum Strength Ranitidine Tablets
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class II · Moderate risk
Equate Maximum Strength Ranitidine Tablets
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class II · Moderate risk
Rite Aid Pharmacy Maximum Strength Ranitidine Tablets
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class II · Moderate risk
Equate Maximum Strength Ranitidine Tablets
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class II · Moderate risk
Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class II · Moderate risk
Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class II · Moderate risk
Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx…
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Class II · Moderate risk
Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx…
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Class II · Moderate risk
Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx…
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Class II · Moderate risk
Losartan Potassium/ Hydrochlorothiazide Tablets
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 9.82 parts per million.
Class II · Moderate risk
Losartan Potassium /Hydrochlorothiazide Tablets
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 9.82 parts per million.
Class II · Moderate risk
Losartan Potassium Tablets
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 9.82 parts per million.
Class II · Moderate risk
Losartan Potassium Tablets
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 9.82 parts per million.
Class II · Moderate risk
Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets
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 II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
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 II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.