Amlodipine - I've heard that this drug has been recalled by FDA. Why hasn't Drugs.Com put this in?
Question posted by lady1947 on 3 Dec 2018
Last updated on 3 December 2018 by ddcmod1
You are not quite correct. Amlodipine has not been recalled.
The recall you have heard about most recently is for the combination products Amlodipine/Valsartan and Amlodipine/Valsartan/Hydrochlorothiazide manufactured by Teva. Notification of the recall of these combination products was posted by Drugs.com immediately upon receipt of the recall issued by the FDA.
You can find more information, including links to the images of the recalled tablets in the FDA Alert below.
Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry
The reason for this recall is because these products contain the drug valsartan, and the ingredient was found to be contaminated with the impurity known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carcinogen. This chemical is typically found in very small amounts in certain foods, drinking water, air pollution, and certain industrial processes.
There have been multiple recalls from a number of manufacturers for products containing contaminated valsartan and losartan, and the investigation is ongoing.
You can find details of the other recalls here: FDA Updates on Angiotensin II Receptor Blocker (ARB) Recalls. This page is updated as more information becomes available.
As I understand it, it was the combo pill with Valsartan, HCTZ, Amlodipine that was recalled. My doctor switched me to Losartan/HCTZ with a separate Amlodipine. I suggest ask your doctor or pharmacist if your version is on the recall list.
high blood pressure, amlodipine, amlodipine/valsartan, valsartan, amlodipine/hydrochlorothiazide/valsartan, fda, drug
- Amlodipine uses and warnings
- Amlodipine / Valsartan uses and warnings
- Valsartan uses and warnings
- Amlodipine / Hydrochlorothiazide / Valsartan uses and warnings
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