Class II · Moderate risk
AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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
AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan HCTZ
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Unit Dose Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Unit Dose Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan and Hydrochlorothiazide Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan and Hydrochlorothiazide Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan/HCTZ 320mg/12.5 mg tablet
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan/HCTZ 160 mg/12.5 mg tablet
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan and Hydrochlorothiazide
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan and Hydrochlorothiazide
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan and Hydrochlorothiazide
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan and Hydrochlorothiazide
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.