American Health Packaging is voluntarily recalling a lot of their blood pressure medication due to a high level of impurity, per the FDA.
The lot is their Valsartan Tablets, USP, at 160 mg, and the unexpected impurity discovered was NDEA, or N-Nitrosodiethylamine.
This is the recalled product:
- Valsartan Tablets USP 160 mg, 100 count Unit Dose Blisters /Carton NDC#: 60687-139-01
(Individual Dose NDC: 60687-139-11)
The FDA says that NDEA naturally occurs in "foods, drinking water, air pollution, and industrial processes" but is also rated as a probable human carcinogen by the International Agency for Research on Cancer.
Valsartan tablets are used to control high blood pressure and to treat heart failure.
This does not mean that patients who were prescribed Valsartan should stop taking their medication, because that could lead to endangerment of health, heart attacks, or even death.
The FDA does suggest that if a patient no longer wishes to take a voluntarily recalled medication, that they seek an alternative rather than stopping their medication immediately.
If you have concerns and wish to contact this manufacturer with medical questions, call Aurobindo Pharma USA, Inc. at 1-866-850-2876 Option 2 or email pvg@aurobindousa.com.
Pictures of the product:
Other recalled medications are :
- Losartan Tablets USP 25 mg, 50 mg, and 100 mg
- Losartan Potassium/Hydrochlorothiazide Combination Tablets
- Valsartan and Amlodipine and Valsartan tablets
- Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide Tablets USP
RELATED: Blood pressure medication recall expands again to include losartan
Pictures of the product:
