Class II · Moderate risk
Equate Maximum Strength Ranitidine Tablets
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Nitrosamine impurities (NDMA/NDEA)
Trace nitrosamine impurities such as NDMA, NDEA or NMBA found above the acceptable daily limit. Nitrosamines are probable human carcinogens that can form during manufacturing or storage. This is the cause behind the large valsartan, losartan and ranitidine (Zantac) recalls.
568 FDA drug recalls with this cause, newest first.
Nitrosamine compounds such as NDMA, NDEA or NMBA are probable human carcinogens that can form during manufacturing or storage. Recalls here trace back to a nitrosamine found above the accepted limit - whether the report names the compound or simply calls it a 'carcinogenic impurity'. It is a newer category, driven by improved testing methods that can now detect impurities that were previously missed, and it is the chemistry behind the large valsartan, losartan and ranitidine (Zantac) recalls.
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.
Class II · Moderate risk
Losartan Potassium Tablets 50 mg 1000 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 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
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
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
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
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 100 mg TABLET BULK 90 count bottles
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 50 mg TABLET BULK 90 count bottles and 1000 count bottles
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 Tablets USP 25 mg 90 film coated tablets Rx…
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Class II · Moderate risk
Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx…
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
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