Class II · Moderate risk
Rifampin Capsules
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
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
Rifampin Capsules
CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
Class II · Moderate risk
Accupril (Quinapril HCl Tablets)
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Class II · Moderate risk
Accupril (Quinapril HCl Tablets)
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Class II · Moderate risk
Accupril (Quinapril HCl Tablets)
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Class II · Moderate risk
Accuretic (quinapril HCl/hydrochlorothiazide)
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk
quinapril HCl/hydrochlorothiazide tablets
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk
quinapril HCl/hydrochlorothiazide tablets
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk
quinapril and hydrochlorothiazide tablets
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk
Accuretic (quinapril HCl/hydrochlorothiazide)
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk
Accuretic (quinapril HCl/hydrochlorothiazide)
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk
Accuretic (quinapril HCl/hydrochlorothiazide)
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk
Accuretic (quinapril HCl/hydrochlorothiazide)
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk
Orphenadrine Citrate Extended-Release Tablets
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Class II · Moderate risk
Metformin 750 mg Extended Release NDC # 70518-2920-00
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk
Irbesartan and Hydrochlorothiazide Tablets USP
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II · Moderate risk
Irbesartan and Hydrochlorothiazide Tablets USP
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II · Moderate risk
Irbesartan Tablets USP
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II · Moderate risk
Irbesartan Tablets USP
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II · Moderate risk
Irbesartan Tablets USP
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
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