Since late summer, there has been a lot of media about certain blood pressure medicines being recalled because they contain an impurity N-nitrosodimethylamine (NDMA) .
The first FDA recall for this issue was around July 2018... but since then the list has been expanding with the most recent recall made on December 4, 2018. Here is a summary of the blood pressure medicines that are affected so far. This list is taken from FDA website:
| 12/04/2018 | Mylan | Valsartan-containing products | Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient | Mylan Pharmaceuticals |
| 11/27/2018 | Teva Pharmaceuticals | Amlodipine/Valsartan Combination Tables and Amlopidine/Valsartan/Hydrochlorothiazide Combination Tablets | Impurity N-nitroso-diethylamine (NDEA) in API | Teva Pharmaceuticals |
| 11/20/2018 | Mylan | Amlodipine and Valsartan Tablets; Valsartan Tablets; Valsartan and Hydrochlorothiazide Tablets | Contain trace amounts of an impurity, N-nitrosodiethylamine (NDEA) | Mylan Pharmaceuticals |
| 11/08/2018 | Losartan | Losartan Potassium Hydrochlorothiazide | Product contains NDEA impurity | Sandoz Inc |
| 10/30/2018 | WP Westminster, more | Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms | due to the presence of an impurity, N-nitrosodiethylamine (NDEA) | ScieGen Pharmaceuticals, Inc |
| 10/26/2018 | Aurobindo Pharma Limited | Irbesartan Drug | Due to the presence of an impurity, N-nitrosodiethylamine (NDEA) | Aurobindo Pharma Limited |
| 08/23/2018 | Torrent Pharmaceuticals Limited | Valsartan/Amlodipine/HCTZ; Valsartan/Amlodipine; and Valsartan tablets | Impurity detected in the API is N-nitrosodimethylamine (NDMA) | Torrent Pharmaceuticals Limited |
| 08/17/2018 | Torrent | Valsartan/Amlodipine/HCTZ Tablets | Impurity detected in the API is N-nitrosodimethylamine (NDMA) | Torrent Pharmaceuticals |
| 08/08/2018 | Camber Pharmaceuticals, Inc. | Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg | Detection of trace amounts of N-Nitrosodimethylamine (NDMA) | Camber Pharmaceuticals, Inc. |
| 07/17/2018 | Actavis | Valsartan and Valsartan Hydrochlorothiazide Tablets | Impurity detected in the API is Nnitrosodimethylamine (NDMA) | Teva Pharmaceuticals USA |
| 07/17/2018 | Prinston Pharmaceutical Inc. dba Solco Healthcare LLC | Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg | Detection of a Trace Amount of Unexpected Impurity, N- nitrosodimethylamine (NDMA) | Prinston Pharmaceutical Inc. dba Solco Healthcare LLC |
| 07/13/2018 | Major Pharmaceuticals | Valsartan tablets, 80mg USP and 160 mg USP | may contain the probable carcinogen Nnitrosodimethylamine (NDMA) | Major Pharmaceuticals |
If your medication is on the recall list, you should have been contacted by your pharmacy. If you are not sure you can always call your pharmacy to find out.
The label on your medication bottle should tell you which company manufactured that medicine.
If your medicine is affected, speak with your physician for an alternative. This requires careful consultation because the type and dosage of medicine you can be switched to depends on your medical history and current health.
Also to note... the medicines on this list are all generics made by different manufacturing companies. So far there has been no recall on the actual brand name product.
Valsartan = generic for Diovan (made by Novartis)
Losartan = generic for Cozaar (made by Merck)
Irbesartan = generic for Avapro (made by Sanofi)
Amlodipine = generic for Norvasc (made by Pfizer)
Brand name medicines cost a lot more than generics. However, with commercial insurance sometimes the company will offer coupons where the co-pay is lowered. Unfortunately, the coupons do not work with medicare patients. Again, consult with your physician about what is best for you.
Hope this helps!
